The Orange Book turns 35 Years Old
Did you ever wonder how the Orange Book got its nickname?
When the first print edition of Approved Drug Products with Therapeutic Equivalence Evaluations was being prepared in October 1980, staff members in the Office of Generic Drugs had to choose a color for the cover. The project manager suggested, "It's almost Halloween. How about orange?" Before long, The Orange Book had become a popular short title for this important publication. More information
Substances Generally Recognized as Safe: Notification Procedure
The FDA announced an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Registerconcerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of the Notification Procedure for Substances Generally Recognized as Safe (GRAS). More information |
Public Comments on Patient-Focused Drug Development for Huntington's and Parkinson's Diseases
FDA has selected Huntington's disease (HD) and Parkinson's disease (PD) as the focus of a public meeting under Patient-Focused Drug Development, an initiative that involves obtaining a better understanding of patient perspectives on the severity of a disease and the available therapies for these conditions. Patient-Focused Drug Development is being conducted to fulfill FDA performance commitments that are part of the reauthorization of PDUFA under Title I of the Food and Drug Safety and Innovation Act. More information
Drug Interactions With Hormonal Contraceptives: Public Health and Drug Development Implications
The FDA announced a public meeting entitled “Drug Interactions with Hormonal Contraceptives: Public Health and Drug Development Implications” and an opportunity for public comment on the topic of drug interactions with hormonal contraceptives (HCs). The goal of this public meeting is to provide an opportunity for FDA to seek input from experts on the public health concerns associated with use of HCs and interacting drugs that might affect efficacy and safety, pharmacokinetic (PK)/pharmacodynamic (PD) considerations in designing drug interaction studies with HCs during drug development, and approaches to translating the results of drug interaction information into informative labeling and communication. The input received may be used to refine FDA's thinking on HC drug interaction study design and interpretation, and labeling communication on drug interaction risk. More information
Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable
FDA's investigational device regulations are intended to encourage the development of new, useful devices in a manner that is consistent with public health, safety, and compliant with ethical standards. Investigators should have freedom to pursue the least burdensome means of accomplishing this goal. However, to ensure that the balance is maintained between product development and the protection of public health, safety, and ethical standards, FDA has established human subject protection regulations addressing requirements for informed consent and institutional review board (IRB) review that apply to all FDA-regulated clinical investigations involving human subjects. In particular, informed consent requirements further both safety and ethical considerations by allowing potential subjects to consider both the physical and privacy risks they face if they agree to participate in a trial. More information
FDA approves new drug to treat hyperkalemia
FDA approved Veltassa (patiromer for oral suspension) to treat hyperkalemia, a serious condition in which the amount of potassium in the blood is too high. Veltassa, a powdered medication that patients mix with water and take by mouth, works by binding potassium in the gastrointestinal tract, decreasing its absorption. In clinical trials, Veltassa was effective in lowering potassium levels in hyperkalemic participants with chronic kidney disease on at least one drug that inhibited the renin-angiotensin-aldosterone system. More information |
FDA approves new treatment for advanced pancreatic cancer
FDA approved Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, to treat patients with advanced (metastatic) pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy.
According to the National Cancer Institute, there will be 48,960 new cases of pancreatic cancer diagnosed in the U.S. in 2015, and nearly the same number of deaths caused by the disease (40,560). Pancreatic cancer can be difficult to diagnose early and treatment options are limited, especially when the disease has spread to other parts of the body (metastatic disease) and surgery to remove the tumor is not possible. More information
FDA approves new therapy for certain types of advanced soft tissue sarcoma
FDA approved Yondelis (trabectedin), a chemotherapy, for the treatment of specific soft tissue sarcomas (STS) – liposarcoma and leiomyosarcoma – that cannot be removed by surgery(unresectable) or is advanced (metastatic). This treatment is approved for patients who previously received chemotherapy that contained anthracycline. More information
FDA approves new treatment for rare metabolic disorder
FDA approved Strensiq (asfotase alfa) as the first approved treatment for perinatal, infantile and juvenile-onset hypophosphatasia (HPP).
HPP is a rare, genetic, progressive, metabolic disease in which patients experience devastating effects on multiple systems of the body, leading to severe disability and life-threatening complications. It is characterized by defective bone mineralization that can lead to rickets and softening of the bones that result in skeletal abnormalities. It can also cause complications such as profound muscle weakness with loss of mobility, seizures, pain, respiratory failure and premature death. Severe forms of HPP affect an estimated one in 100,000 newborns, but milder cases, such as those that appear in childhood or adulthood, may occur more frequently. More information
FDA approves first-of-its-kind product for the treatment of melanoma
FDA approved Imlygic (talimogene laherparepvec), the first FDA-approved oncolytic virus therapy, for the treatment of melanoma lesions in the skin and lymph nodes. Imlygic, a genetically modified live oncolytic herpes virus therapy, is used to treat melanoma lesions that cannot be removed completely by surgery. Imlygic is injected directly into the melanoma lesions, where it replicates inside cancercells and causes the cells to rupture and die. More information
FDA approves Yervoy to reduce the risk of melanoma returning after surgery
FDA expanded the approved use of Yervoy (ipilimumab) to include a new use as adjuvant therapy for patients with stage III melanoma, to lower the risk that the melanoma will return following surgery. Yervoy, administered intravenously, was originally approved in 2011 to treat late-stage melanoma that cannot be removed by surgery. More information
For more information on drug approvals or to view prescribing information and patient information, please visit Drugs at FDA or DailyMed
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For more important safety information on human drugs, medical devices, dietary supplements and more, or to report a problem with a medical product, please visit MedWatch. To receive MedWatch Safety Alerts by email subscribe here.
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Entacapone: Drug Safety Communication - FDA Review Found No Increased Cardiovascular Risks
An FDA safety review has found no clear evidence of an increased risk of heart attacks, stroke, or other cardiovascular events associated with the use of entacapone for the treatment of Parkinson’s disease. As a result, recommendations for using Comtan (entacapone) and Stalevo (a combination of entacapone, carbidopa, and levodopa) will remain the same in the drug labels. More information |
Hepatitis C Treatments Viekira Pak and Technivie: Drug Safety Communication - Risk of Serious Liver Injury
FDA is warning that hepatitis C treatments Viekira Pak and Technivie can cause serious liver injury mostly in patients with underlying advanced liver disease. As a result, FDA is requiring the manufacturer to include information about serious liver injury adverse events to the Contraindications, Warnings and Precautions, Postmarketing Experience, and Hepatic Impairment sections of the Viekira Pak and Technivie drug labels. More information
Kayexalate (sodium polystyrene sulfonate): Drug Safety Communication - FDA Requires Drug Interaction Studies
FDA is requiring the Kayexalate manufacturer to conduct studies to investigate Kayexalate’s potential to bind to other medications administered by mouth – drug interactions that could affect how well the other medications work.
The approved labeling for Kayexalate describes its potential to decrease absorption of lithium and thyroxine; however, extensive drug-drug interaction studies with Kayexalate have not been performed. During FDA’s review of another potassium-lowering drug, Veltassa (patiromer), we found that Veltassa bound to about half of the medications tested, some of which are commonly used in patients who require potassium-lowering drugs. Such binding could decrease the effects of these medications. The label for Veltassa contains a warning not to take other orally administered medications within 6 hours of taking Veltassa. More information
Myocardial Protection System (MPS) Delivery Sets by Quest Medical: Recall - Intermittent Seal Failure During Use
The identified lots of MPS Delivery sets have shown a possible seal failure along the blood source channel of main pump cassette, resulting in blood loss from the bypass circuit and interruption of cardioplegia solution delivery. The firm has received twenty complaints alleging this seal failure which have resulted in 16 instances of patient blood loss during surgery. There have been no reports of patient injuries as a result of the alleged issue to date. More information
Auvi-Q (epinephrine injection, USP): Recall - Potential Inaccurate Dosage Delivery
Sanofi US is voluntarily recalling all Auvi-Q (epinephrine injection, USP). The recall involves all Auvi-Q currently on the market and includes both the 0.15 mg and 0.3 mg strengths for hospitals, retailers and consumers. This includes lot number 2299596 through 3037230, which expire March 2016 through December 2016. The products have been found to potentially have inaccurate dosage delivery. See the Press Release for product photos. More information
Downing Labs, LLC Sterile Compounded Products: Recall - Lack of Sterility Assurance
Downing Labs, LLC is voluntarily recalling all lots of sterile products compounded and packaged by Downing Labs and that remain within expiry due to concerns over sterility assurance. The products were distributed nationwide and in the UK to patients and providers between April 20, 2015 and September 15, 2015. If there is a contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening. More information
FDA advisory committee meetings are free and open to the public. No prior registration is required to attend. 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. Click on "more information" for details about each meeting.
Please visit FDA’s Advisory Committee webpage for more information. Please visit Meetings, Conferences, & Workshops for more information on other agency meetings.
Joint Meeting of the Antimicrobial Drugs Advisory Committee (Formerly Known as the Anti-Infective Drugs Advisory Committee) and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting (November 5)
The committees will discuss the risks and benefits of the systemic fluoroquinolone antibacterial drugs for the treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis in patients who have chronic obstructive pulmonary disease, and uncomplicated urinary tract infections in the context of available safety information and the treatment effect of antibacterial drugs in these clinical conditions. More information
Anesthetic and Analgesic Drug Products Advisory Committee (November 6)
The committee will discuss new drug application (NDA) 022225, sugammadex sodium injection, submitted by Organon USA Inc., a subsidiary of Merck & Co., Inc., for the proposed indication of reversal of moderate or deep neuromuscular blockade (NMB) induced by rocuronium or vecuronium. More information
Drug Interactions with Hormonal Contraceptives; Public Health and Drug Development Implications; Public Meeting (November 9)
FDA is announcing a public meeting entitled “Drug Interactions with Hormonal Contraceptives: Public Health and Drug Development Implications” and an opportunity for public comment on the topic of drug interactions with hormonal contraceptives (HCs). More information
Public Workshop - Clinical Trial Designs for Emerging Infectious Diseases (November 9-10)
This workshop will explore the ethical and methodological assumptions behind the choice of different trial designs, describe different types of emerging infectious diseases of concern, and then explore several clinical trial designs for both vaccines and therapeutic products. Participants will discuss the scientific, ethical, and practical issues considered in the choice of specific trial designs, and the generalizability of these designs for other types of emerging infectious diseases. More information
Scientific Workshop on Labeling “Lower” Dose Estrogen-Alone Products for Symptoms of Vulvar and Vaginal Atrophy (VVA) (November 10)
This scientific workshop will provide an opportunity for FDA to obtain input from experts on several topics related to the product label of lower dose estrogen-alone products approved solely for the treatment of moderate to severe symptoms of VVA due to menopause. More information
Public Workshop - Standards Based Approach to Analytical Performance Evaluation of Next Generation Sequencing In Vitro Diagnostic Tests (November 12)
The Food and Drug Administration (FDA) is announcing a public workshop entitled “Standards Based Approach to Analytical Performance Evaluation of Next Generation Sequencing In Vitro Diagnostic Tests.” The purpose of this workshop is to obtain feedback on possible analytical standards and approaches to develop or build on existing standardization efforts in order to optimize FDA’s regulation of next-generation sequencing (NGS)-based in vitro diagnostic tests. Comments and suggestions generated through this workshop will also guide the use of regulatory science to advance the further development of appropriate and relevant performance standards for evaluation of next generation sequencing in vitro diagnostic tests that produce results on variation in the human genome. More information
Public Workshop - Use of Databases for Establishing the Clinical Relevance of Human Genetic Variants (November 13)
The Food and Drug Administration (FDA) is announcing a public workshop entitled: “Use of Databases for Establishing the Clinical Relevance of Human Genetic Variants”. The purpose of this workshop is to obtain feedback on ways in which FDA can use curated databases containing information about human genetic variation as sources of valid clinical evidence for the Agency’s oversight of the next-generation sequencing (NGS)-based in vitro diagnostic tests (IVDs). Comments and suggestions generated through this workshop will guide the development of best practices and/or regulatory standards for reliance on external curated databases. More information
Vaccines and Related Biological Products Advisory Committee (November 13)
The committee will meet in open session to discuss considerations for evaluation of the safety and effectiveness of vaccines administered to pregnant women to protect the infant. More information
Joint Meeting of the Cellular, Tissue and Gene Therapies Advisory Committee and Oncologic Drugs Advisory Committee (November 18)
The committees will discuss the safety and efficacy of Biologics License Application (BLA) 125593, Mycobacterium phlei Cell wall-Nucleic Acid complex (MCNA), submitted by Telesta Therapeutics Inc. The proposed indication (use) for this product is treatment of non-muscle invasive bladder cancer (NMIBC) at high risk of recurrence or progression in adult patients who failed prior Bacillus Calmette-Guérin (BCG) immunotherapy, e.g., in patients who are BCG-refractory or BCG-relapsing. More information
Science Board to the FDA (November 18)
The Science Board will be provided with an update from the CERSI Evaluation Subcommittee and the ORA Food Emergency Response Network Evaluation Subcommittee. The Board will hear about the scope of FDA’s involvement in precision medicine, as well as an overview of specific health informatics initiatives including precisionFDA, Open FDA, and Chillax. The Board will also hear about FDA’s laboratory safety initiative. A recipient of one of the FY2014 Scientific Achievement Awards (selected by the Board) will provide an overview of the activities for which the award was given. More information
Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (November 19)
Information will be presented to gauge investigator interest in exploring potential pediatric development plans for two products in various stages of development for adult cancer indications. The subcommittee will consider and discuss issues concerning diseases to be studied, patient populations to be included, and possible study designs in the development of these products for pediatric use. The discussion will also provide information to the Agency pertinent to the formulation of written requests for pediatric studies, if appropriate. More information
Public Workshop - Neurodiagnostics and Non-Invasive Brain Stimulation Medical Devices (November 19-20)
The Food and Drug Administration (FDA) is announcing the following two-day public workshop entitled, “Neurodiagnostics and Non-Invasive Brain Stimulation Medical Devices Workshop.” The focus of the first day of the workshop will be cognitive assessment medical devices, which are intended to provide healthcare professionals with an evaluation of cognitive function through non-invasive measurements. The focus of the second day of the workshop will be non-invasive brain stimulation medical devices, which are medical devices that are intended to improve, affect, or otherwise modify the cognitive function of a normal individual (i.e., without a treatment objective) by means of non-invasive electrical or electromagnetic stimulation to the head. The purpose of this workshop is to obtain public input and feedback on scientific, clinical, and regulatory considerations associated with medical devices for assessing and influencing cognitive function. More information
Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting (November 24)
The committee will discuss new drug application (NDA) 206031, drisapersen solution for injection, sponsored by BioMarin Pharmaceutical Inc., for the treatment of patients with Duchenne muscular dystrophy with mutations in the dystrophin gene that are amenable to treatment with exon 51 skipping as determined by genetic testing. More information
Patient and Consumer Stakeholder Meetings - MDUFA Reauthorization (November 30)
FDA will host meetings to discuss the reauthorization of the Medical Device User Fee Amendments (MDUFA). During these meetings, representatives from patient and consumer advocacy groups can discuss their views on reauthorization and provide suggestions for improving the program. The statutory authority for MDUFA expires September 30, 2017. At that time, new legislation will be required for FDA to continue collecting user fees for the medical device program. More information
Psychopharmacologic Drugs Advisory Committee Meeting (December 1)
The committee will discuss the efficacy and safety data for new drug application (NDA) 21164, gepirone hydrochloride extended-release tablets, submitted by Fabre-Kramer Pharmaceuticals, Inc., for the proposed indication of major depressive disorder. More information
FDA JHU CERSI Co-sponsor Conference on Assessing Safety and Efficacy for a Diverse Population in Clinical Trials (December 2)
This educational workshop will describe the significance of population diversity in evaluating medical products and advance discussion on methodological challenges in subgroup analyses in the evaluation of medical products for diverse populations. More information
Pulmonary-Allergy Drugs Advisory Committee (December 9)
The committee will discuss biologics license application 761033, reslizumab for injection, submitted by Teva Pharmaceutical Industries, Ltd., for the proposed indication to reduce exacerbations, relieve symptoms, and improve lung function in adults and adolescents 12 years of age and above, with asthma and elevated blood eosinophils, who are inadequately controlled on inhaled corticosteroids. More information
Joint Meeting of the Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and the Risk Management Advisory Committee (December 10)
The committees will discuss the safety of codeine in children 18 years of age and younger. Codeine (most often in combination with acetaminophen) is used for the treatment of pain in children; however, it is contraindicated for the management of pain after tonsillectomy and/or adenoidectomy. Codeine (in combination with other medicines) is used for the relief of cough associated with upper respiratory allergies or the common cold in children. More information
Patient and Consumer Stakeholder Meetings - MDUFA Reauthorization (December 18)
FDA will host meetings to discuss the reauthorization of the Medical Device User Fee Amendments (MDUFA). During these meetings, representatives from patient and consumer advocacy groups can discuss their views on reauthorization and provide suggestions for improving the program. The statutory authority for MDUFA expires September 30, 2017. At that time, new legislation will be required for FDA to continue collecting user fees for the medical device program. More information |
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