Recall: Liquid Products Manufactured by PharmaTech and Distributed by Leader Brand, Major Pharmaceuticals, and Rugby Laboratories - Possible Product Contamination
Through recent communication with FDA, the distribution firm Rugby Laboratories learned of a potential issue with a product manufactured by PharmaTech LLC. The FDA informed Rugby Laboratories that it received several adverse event reports of B. cepacia infections in patients, which may be linked to PharmaTech LLC manufactured Diocto Syrup or Diocto Liquid (docusate sodium solutions). In response, Rugby Laboratories issued a voluntary recall on August 3, 2017, of the PharmaTech LLC manufactured Diocto Syrup and Diocto Liquid. As a precautionary measure based on additional information received from the FDA, the three distribution firms are recalling all lots within expiry of all liquid products manufactured by PharmaTech LLC. More information
Warning: Balguti Kesaria Ayurvedic Medicine - High Levels Of Lead
FDA is warning parents and caregivers not to use “Balguti Kesaria (or Kesaria Balguti) Ayurvedic Medicine” due to the risk of lead poisoning. This product is sold online and manufactured by multiple companies, including Kesari Ayurvedic Pharmacy in India. Individuals have also mailed or brought the product into the United States. “Balguti Kesaria Ayurvedic Medicine” is used with infants and children for a variety of conditions including rickets, cough and cold, worms and dentition (teething). FDA has not reviewed this product for safety or effectiveness. Exposure to lead can cause serious damage to the central nervous system, the kidneys and the immune system. In children, chronic exposure to lead—even at low levels—is associated with impaired cognitive function, including reduced IQ, behavioral difficulties, and other problems. More information |
Recall: Pravastatin Sodium Tablets by International Laboratories - Mislabeling
International Laboratories, LLC is voluntarily recalling one (1) Lot of Pravastatin Sodium Tablets USP 40 mg packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as Pravastatin Sodium Tablets USP 40 mg but contained Bupropion Hydrochloride XL 300 mg tablets. The affected product is NDC# 54458-925-16; Lot# 115698A. This lot of Pravastatin Sodium Tablets USP 40 mg was recalled when International Laboratories, LLC was informed by a pharmacist that one 30ct bottle of this product was mislabeled and contained Bupropion Hydrochloride XL 300 mg tablets. Pravastatin Sodium Tablets are indicated as an adjunctive therapy to diet when the response to a diet restricted in saturated fat and cholesterol and other non-pharmacologic measures alone has been inadequate. It is used to treat children and adolescent patients ages 8 years and older with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. More information
International Laboratories, LLC is voluntarily recalling one (1) Lot of Pravastatin Sodium Tablets USP 40 mg packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as Pravastatin Sodium Tablets USP 40 mg but contained Bupropion Hydrochloride XL 300 mg tablets. The affected product is NDC# 54458-925-16; Lot# 115698A. This lot of Pravastatin Sodium Tablets USP 40 mg was recalled when International Laboratories, LLC was informed by a pharmacist that one 30ct bottle of this product was mislabeled and contained Bupropion Hydrochloride XL 300 mg tablets. Pravastatin Sodium Tablets are indicated as an adjunctive therapy to diet when the response to a diet restricted in saturated fat and cholesterol and other non-pharmacologic measures alone has been inadequate. It is used to treat children and adolescent patients ages 8 years and older with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. More information
FDA Alert: Sterile Drug Products from Vital Rx, dba Atlantic Pharmacy and Compounding - Lack of Sterility Assurance
FDA is alerting health care professionals and patients not to use drug products intended to be sterile that are produced and distributed nationwide by Vital Rx Inc., dba Atlantic Pharmacy and Compounding, Pompano Beach, Florida, due to lack of sterility assurance. During FDA’s recent inspection of Atlantic Pharmacy, investigators observed insanitary conditions, including poor sterile production practices, which raise concerns about Atlantic Pharmacy’s ability to assure the sterility of the drug products it produces. More information
FDA is alerting health care professionals and patients not to use drug products intended to be sterile that are produced and distributed nationwide by Vital Rx Inc., dba Atlantic Pharmacy and Compounding, Pompano Beach, Florida, due to lack of sterility assurance. During FDA’s recent inspection of Atlantic Pharmacy, investigators observed insanitary conditions, including poor sterile production practices, which raise concerns about Atlantic Pharmacy’s ability to assure the sterility of the drug products it produces. More information
Recall: Lorazepam Oral Concentrate, USP 2mg/mL by Amneal Pharmaceuticals - Misprinted Dosing Droppers
Amneal Pharmaceuticals LLC is voluntarily recalling 13 lots of Lorazepam Oral Concentrate, USP 2mg/mL, to the Consumer level due to a defect in the dropper markings. The Lorazepam Oral Concentrate, USP 2mg/mL, product is packaged with a dosing dropper, supplied to Amneal by a third party. In a few instances, the dropper is printed with the dose markings in reverse number order, has no dose markings or has dose markings that are shifted. Amneal learned about the issue from a Consumer's report. To date no adverse events related to these dropper defects have been reported to Amneal. See the press release for product photos and a listing of affected lot numbers. There is a significant likelihood that the dropper marking errors will result in dispensing either less than, or more than, the prescribed dose. There is a significant probability of a serious health consequence if more than the prescribed dose is dispensed and potential serious adverse events include: drowsiness causing trauma; increased anxiety; increased accidental injury to self or others (e.g., hip fracture, motor vehicle accident); which in the most serious circumstances could result in permanent decreased function or death. More information
Amneal Pharmaceuticals LLC is voluntarily recalling 13 lots of Lorazepam Oral Concentrate, USP 2mg/mL, to the Consumer level due to a defect in the dropper markings. The Lorazepam Oral Concentrate, USP 2mg/mL, product is packaged with a dosing dropper, supplied to Amneal by a third party. In a few instances, the dropper is printed with the dose markings in reverse number order, has no dose markings or has dose markings that are shifted. Amneal learned about the issue from a Consumer's report. To date no adverse events related to these dropper defects have been reported to Amneal. See the press release for product photos and a listing of affected lot numbers. There is a significant likelihood that the dropper marking errors will result in dispensing either less than, or more than, the prescribed dose. There is a significant probability of a serious health consequence if more than the prescribed dose is dispensed and potential serious adverse events include: drowsiness causing trauma; increased anxiety; increased accidental injury to self or others (e.g., hip fracture, motor vehicle accident); which in the most serious circumstances could result in permanent decreased function or death. More information
Comunicaciones de la FDA sobre la seguridad de los medicamentos en español
Descargo de responsabilidad: La FDA reconoce la necesidad de proporcionar información importante sobre seguridad de los medicamentos en idiomas distintos al inglés. Hacemos lo mejor posible para proporcionar versiones en español precisas y oportunas de nuestras Comunicaciones de Seguridad de Medicamentos. Sin embargo, en caso que existiera discrepancias entre las versiones en inglés y la de español, la información contenida en la versión en inglés es la que se considera como versión oficial. Si tiene alguna pregunta, por favor contáctese con Division of Drug Information en druginfo@fda.hhs.gov. Comunicaciones de la FDA |
FDA knows the major public health consequences that can result from drug shortages. These shortages occur for many reasons including manufacturing and quality problems, delays and discontinuations. When issues are discovered, FDA works closely with the company to address risks involved to prevent harm to patients. FDA also considers the impact a shortage would have on patient care and access and works with the company to restore supplies while also ensuring safety for patients. More information
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Biologic Shortage Voluntarily Reported by Manufacturers During the Past 2 Weeks:
Drug Discontinuation Voluntarily Reported by Manufacturers During the Past 2 Weeks:
- Beclomenthasone Dipropionate HFA Inhalation Aerosol
- Diatrizoate Meglumine and Diatrizoate Sodium (MD-76R) Injection
Information about blood and biologic shortages, resolved shortages, and discontinuations
La FDA reconoce las consecuencias significativas para la salud pública que pueden resultar de la escasez de medicamentos y hace un gran esfuerzo dentro de sus facultades legales para abordar yprevenir la escasez de medicamentos. La escasez se produce por muchas razones, incluyendo problemas de fabricación y calidad, retrasos y discontinuación del producto. Cuando los problemas son descubiertos por la empresa o el público y reportados a la FDA o se descubren por inspecciones de la FDA, la FDA trabaja en estrecha colaboración con la empresa para hacer frente a los riesgosinvolucrados y evitar daños a los pacientes. La FDA también considera el impacto que una escaseztendría en la atención médica del paciente y al acceso del producto y trabaja con la empresa pararestablecer el suministro al tiempo que garantiza la seguridad de los pacientes. Más información
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FDA expands ibrutinib indications to chronic GVHDFDA has approved ibrutinib (Imbruvica, Pharmacyclics LLC) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy. This is the first FDA-approved therapy for the treatment of cGVHD. This is the first FDA-approved therapy for the treatment of cGVHD. Approval was based on Study PCYC-1129-CA (NCT02195869), an open-label, multi-center, single-arm clinical trial enrolling 42 patients with cGVHD after failure of first-line corticosteroid therapy and requiring additional therapy. The majority of patients (88%) had at least two organs involved at baseline. The most common organs involved were mouth (86%), skin (81%), and gastrointestinal tract (33%). More information
FDA approves first treatment for certain types of poor-prognosis acute myeloid leukemiaFDA has approved Vyxeos for the treatment of adults with two types of acute myeloid leukemia (AML): newly diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Vyxeos is a fixed-combination of chemotherapy drugs daunorubicin and cytarabine. “Vyxeos combines two commonly used chemotherapies into a single formulation that may help some patients live longer than if they were to receive the two therapies separately,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. AML is a rapidly progressing cancer that forms in the bone marrow and results in an increased number of white blood cells in the bloodstream. The National Cancer Institute at the National Institutes of Health estimates that approximately 21,380 people will be diagnosed with AML this year; approximately 10,590 patients with AML will die of the disease in 2017. More information
FDA approves Mavyret for Hepatitis C
FDA has approved Mavyret (glecaprevir and pibrentasvir) to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis. Mavyret is also approved for adult patients with HCV genotype 1 infection who have been previously treated with a regimen either containing an NS5A inhibitor or an NS3/4A protease inhibitor but not both. Mavyret is the first treatment of eight weeks duration approved for all HCV genotypes 1-6 in adult patients without cirrhosis who have not been previously treated. Standard treatment length was previously 12 weeks or more. More information |
For information on drug approvals or to view prescribing information and patient information, please visit Drugs@FDA or DailyMed.
View FDA's Comments on Current Draft Guidance page, for a list of current draft guidances and other topics of interest for patients and caregivers.
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On August 3, 2017, Congress passed the FDA Reauthorization Act (FDARA) of 2017. This new legislation reauthorizes the user fee programs necessary for the continued support of the agency’s pre-market evaluation of prescription drugs, medical devices, generic drugs, and biosimilar products. The timely reauthorization of these programs ensures continuity for our medical product review programs and is crucial to supporting our mission of protecting and promoting public health.
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Federal judge enters consent decree against outsourcing facility Isomeric Pharmacy Solutions
U.S. District Judge Robert J. Shelby entered a consent decree of permanent injunction yesterday between the United States and Isomeric Pharmacy Solutions of Salt Lake City, Utah, two of the company’s co-owners, William O. Richardson and Rachael S. Cruz, and chief operating officer Jeffery D. Brown. The consent decree prohibits Isomeric, its owners and chief operating officer from manufacturing, processing, packing, holding, or distributing drugs until they comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its regulations, in addition to other requirements. According to the complaint for permanent injunction, Isomeric manufactured and distributed purportedly sterile drug products, including injectable and ophthalmic drugs that were adulterated because the drugs were made under insanitary conditions and in violation of current good manufacturing practice requirements under the FD&C Act. Drugs prepared, packed, or held under insanitary conditions may have been contaminated with filth or otherwise harmful if given to patients. The complaint also alleges that Isomeric manufactured and distributed unapproved drugs and drugs that were misbranded because their labeling did not bear adequate directions for use. More information
U.S. District Judge Robert J. Shelby entered a consent decree of permanent injunction yesterday between the United States and Isomeric Pharmacy Solutions of Salt Lake City, Utah, two of the company’s co-owners, William O. Richardson and Rachael S. Cruz, and chief operating officer Jeffery D. Brown. The consent decree prohibits Isomeric, its owners and chief operating officer from manufacturing, processing, packing, holding, or distributing drugs until they comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its regulations, in addition to other requirements. According to the complaint for permanent injunction, Isomeric manufactured and distributed purportedly sterile drug products, including injectable and ophthalmic drugs that were adulterated because the drugs were made under insanitary conditions and in violation of current good manufacturing practice requirements under the FD&C Act. Drugs prepared, packed, or held under insanitary conditions may have been contaminated with filth or otherwise harmful if given to patients. The complaint also alleges that Isomeric manufactured and distributed unapproved drugs and drugs that were misbranded because their labeling did not bear adequate directions for use. More information
In this section you will find a comprehensive list of all the meetings that the FDA is involved with. The meetings may include advisory committee meetings, public workshops and public conferences that are seeking to hear from patients and caregivers.
Most FDA meetings are free to the public and do not require the public to register. Interested persons may present data, information, or views, orally at the meeting, or in writing, on issues pending before the committee. Other types of meetings listed may require prior registration and fees.
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View FDA's Patient Network Calendar of Public Meetings page for a complete list of meetings and workshops.
For additional information on other agency meetings please visit Meetings, Conferences, & Workshops.
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Should You Put Sunscreen on Infants? Not UsuallyYou’re at the beach, slathered in sunscreen. Your 5-month-old baby is there, too. Should you put sunscreen on her? Not usually, according to Hari Cheryl Sachs, M.D., a pediatrician at FDA. “The best approach is to keep infants under 6 months out of the sun,” Sachs says, “and to particularly avoid exposure to the sun in the hours between 10 a.m. and 2 p.m., when ultraviolet (UV) rays are most intense.” Sunscreens are recommended for children and adults. What makes babies so different? “Babies’ skin is less mature compared to adults, and infants have a higher surface-area to body-weight ratio compared to older children and adults,” explains Sachs. “Both these factors mean that an infant’s exposure to the chemicals in sunscreens may be much greater, increasing the risk of side effects from the sunscreen.” More information
4 Medication Safety Tips for Older AdultsWhether you’re settling into your sixties or heading into your ninth decade, be careful when taking prescription and over-the-counter medicines, herbal preparations, and supplements. And if you’re caring for older loved ones, help them stay safe, too. Why the special concern? The older you get, the more likely you are to use additional medicines, which can increase the chance of harmful drug effects, including interactions. And, as you age, physical changes can affect the way medicines are handled by your body, leading to potential complications. For instance, your liver and kidneys may not work as well, which affects how a drug breaks down and leaves your body. “There is no question that physiology changes as we age. Many chronic medical conditions don’t even appear until our later years,” explains RADM (Ret.) Sandra L. Kweder, M.D., F.A.C.P., a medical officer at the U.S. Food and Drug Administration. “It’s not that people are falling to pieces; some changes are just part of the normal aging process.” Read for important safety tips.
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5 Tips for Traveling to the U.S. With Medications
You’re returning from a trip overseas and want to bring back over-the-counter drugs from Europe that aren’t available here. Can you? Your mother-in-law is visiting from Mexico to help with the new baby and runs out of her blood pressure medication. Can she refill her prescription at a U.S. pharmacy? Your foreign exchange student forgot his allergy medication. Can his parents mail it to him from Japan? These are just some of the questions people ask the Food and Drug Administration’s Division of Drug Information, says LCDR Lindsay E. Wagner, an FDA pharmacist—although not every question the Division is asked falls under FDA’s regulatory authority. Read the 5 tips |
More Consumer Updates
For previously published Consumer Update articles that are timely and easy-to-read and cover all FDA activities and regulated products. More information
For previously published Consumer Update articles that are timely and easy-to-read and cover all FDA activities and regulated products. More information
En Español
La información en esta página es para el público en general, y para profesionales y educadores de salud. Esta información puede ser distribuida y publicada sin previa autorización. En Español
La información en esta página es para el público en general, y para profesionales y educadores de salud. Esta información puede ser distribuida y publicada sin previa autorización. En Español
FDA to Exercise Enforcement Discretion for the Use and Labeling of Ultrafiltered Milk in Certain CheesesFDA has issued guidance to industry that it will exercise enforcement discretion regarding the use and labeling of fluid ultrafiltered milk (UF milk) and fluid ultrafiltered nonfat milk (UF nonfat milk) to make certain cheeses and related cheese products. Ultrafiltered milk is milk that is mechanically filtered to concentrate large compounds, like proteins. In the process, smaller compounds, like lactose, are removed, along with water and mineral salts. The resulting protein concentrate is less expensive to ship than milk. The FDA is taking this action now due to recent changes in some export markets that have caused the U.S. dairy industry to experience an oversupply and pricing challenges with domestically produced UF milk. The exercise of enforcement discretion is intended to mitigate, in part, the impact on U.S. companies producing UF milk, while the FDA considers rulemaking concerning the issues about the use and labeling of UF milk and UF nonfat milk in certain cheeses and cheese products. Guidance Document
The Safety Reporting PortalThe Safety Reporting Portal (SRP) streamlines the process of reporting product issues to the Food and Drug Administration and the National Institutes of Health. Whatever your role, (manufacturer, health care professional, researcher, public health official, or concerned citizen), when you submit a safety report through this Portal, you make a vital contribution to the safety of America's food supply, medicines, and other products that touch us all. More information
Center for Food Safety and Applied NutritionThe Center for Food Safety and Applied Nutrition, known as CFSAN, carries out the mission of FDA. The Center provides services to consumers, domestic and foreign industry and other outside groups regarding field programs; agency administrative tasks; scientific analysis and support; and policy, planning and handling of critical issues related to food and cosmetics. More information
Food Facts for YouThe Center for Food Safety and Applied Nutrition, known as CFSAN, issues food facts for consumers to keep you and your family safe. More information
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Animal Health LiteracyAnimal Health Literacy means timely information for the benefit of all animals and their humans. With continuous communication and outreach, the Center for Veterinary Medicine (CVM) strives to enhance the public trust, promote safe and effective use of the animal health products we regulate, and share our scientific endeavors. CVM provides reliable, science-based information to promote animal and human health. More information and Publicaciones en Español del FDA
Animal and Veterinary UpdatesAnimal and veterinary updates provide information to keep your pets healthy and safe. More information
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How to Report a Pet Food Complaint
You can report complaints about a pet food product electronically through the Safety Reporting Portal or you can call your state’s FDA Consumer Complaint Coordinators. Please provide as much information as possible in your complaint, such as exact name of product, type of container, lot number, UPC codes, how the food was stored, and purchase date and exact location where purchased. If possible, please save the original packaging until the pet food has been consumed. The packaging contains IMPORTANT information often needed to identify the variety of pet food, the manufacturing plant, and the production date. More information |
FDA to expand public education campaign to address youth e-cigarette use
The FDA announced plans to expand its “The Real Cost” public education campaign to include messaging to teens about the dangers of using e-cigarettes and other electronic nicotine devices (ENDS) this fall, while developing a full-scale campaign to launch in 2018. This effort is a part of the agency’s new comprehensive plan for tobacco and nicotine regulation, as well as ongoing efforts to educate youth about, and protect them from, the dangers associated with using all tobacco products. It is the first time the FDA will be utilizing public health education to specifically target youth use of e-cigarettes or other ENDS.
Comments invited as FDA reviews “modified risk” tobacco product applications
The public can now comment on modified risk tobacco product (MRTP) applications submitted by Philip Morris Products S.A., for its IQOS system and three types of Marlboro Heatstick products. By law, tobacco products may not be marketed as being less harmful or presenting lower risk of tobacco-related disease without a written order from FDA, and there are no authorized MRTPs currently on the market in the United States. You can view related Philip Morris Products S.A. documents as they become publicly available, and comment through Dec. 12. |
FDA releases age calculator app for tobacco retailersTakings steps to protect youth from the harms of tobacco, the FDA recently released a voluntary smartphone application, “FDA Age Calculator,” on the Google Play and iTunes app stores designed to help tobacco retailers comply with age restriction laws. Retailers will now be able to use their personal smartphones to help determine if a purchaser is old enough under federal law to buy tobacco products. Find out more about FDA’s efforts to prevent tobacco use among youth.
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Center for Tobacco Products updated safety reporting portal
CTP recently updated its Safety Reporting Portal, an online tool for reporting suspected problems with tobacco products. Whether you’re a consumer, manufacturer, clinical investigator, or health professional, let FDA know about products that seem to be damaged, defective, contaminated, or that smell or taste wrong. More information and to report a safety concern online. |
How cigarettes are made and how you can make a plan to quitEver wonder why it’s so hard to kick smoking to the curb? Well, we’ve got an answer! CTP created an infographic that explores how cigarettes are made, highlighting how their very design may be an obstacle to quitting. As people across the country pledge to quit smoking, consider sharing this infographic with someone who could benefit.
Missed the inaugural issue of CTPConnect?
FDA’s Center for Tobacco Products (CTP) recently published its newest issue of CTPConnect, a plainspoken digest with the latest stories from the Center. Want the full experience? Sign up today to receive the next issue of CTPConnect and other important updates from CTP directly to your inbox. |
Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)
The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" [FD&C Act, sec. 201(i)]. Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product. More information
Bad reaction to a cosmetic? FDA needs to know
What do you do if you have a reaction after using a cosmetic product? First, stop using the product and contact your healthcare provider. Next, please report it to FDA. Here’s why that next step is so important: Cosmetic products aren’t required by law to have FDA approval before they go on the market. Companies that market cosmetics have a legal responsibility to ensure product safety, but FDA can only take action if the product is shown to be unsafe after the product is on the market. And, because the law doesn’t require cosmetic companies to share customer complaints or other safety information with FDA, voluntary reports from consumers and healthcare providers are one of the best ways for FDA to learn about any problems. Cosmetics include a range of products people use every day, such as moisturizers, makeup, shampoos and conditioners, face and body washes, deodorants, nail care products, hair dyes and relaxers, and tattoos. More information |
Recalls and Alerts
To see safety alerts and recent recalls related to cosmetics and other products regulated by FDA. More information
To see safety alerts and recent recalls related to cosmetics and other products regulated by FDA. More information
What to watch for, how to report
You can report an allergic reaction, a rash, redness, burn, hair loss, headache, infection, illness, or any other unexpected reaction, whether or not it required medical treatment. You can also report a bad smell, color change, or other sign of contamination. You can choose the way you’d prefer to report:
You can report an allergic reaction, a rash, redness, burn, hair loss, headache, infection, illness, or any other unexpected reaction, whether or not it required medical treatment. You can also report a bad smell, color change, or other sign of contamination. You can choose the way you’d prefer to report:
- Call an FDA Consumer Complaint Coordinator if you want to speak directly to a person about your problem.
- Complete an electronic Voluntary MedWatch form online.
- Complete a paper Voluntary MedWatch form that you can mail to FDA.
Information about Expanded Access
Expanded access, sometimes called "compassionate use," is the use outside of a clinical trial of an investigational medical product (i.e., one that has not been approved by FDA). FDA is committed to increasing awareness of and knowledge about its expanded access programs and the procedures for obtaining access to human investigational drugs (including biologics) and medical devices. More information |
Learn about your responsibilities under the expanded access pathway, how to submit a request for expanded access for an individual patient (including for emergency use), which forms to use, FDA contacts and more. Information for Physicians
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Learn about what your physician should do before submitting a request for individual patient expanded access use of an investigational medical product, who may be eligible for expanded access, associated costs, FDA contacts and more. Information for Patients
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FDA Patient Network
The FDA Patient Network contains a series of webpages, webinars and presentations on topics related to patient engagement, FDA regulations, understanding medical product (Drugs, Biologics, and Devices) approval and medical product safety updates, Take me to the FDA Patient Network , Follow uson twitter or take me to FDA Webinars.
FDA Basics
Each month, different centers and offices at FDA will host an online session where the public can ask questions to senior FDA officials about a specific topic or just listen in to learn more about FDA. More information
Educational Videos
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