CDER Small Business Update: New Guidance Documents

The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business

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1. Guidances for Industry and Investigators on Safety Reporting Requirements for Investigational New Drug Applications and Bioavailability/Bioequivalence Studies, and a Small Entity Compliance Guide
FDA is announcing the availability of two guidances for industry and investigators entitled “Safety Reporting Requirements for INDs and BA/BE Studies” and “Safety Reporting Requirements for INDs and BA/BE Studies—Small Entity Compliance Guide.” These guidances are intended to help sponsors and investigators comply with the requirements in the final rule entitled “Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans,” published in the Federal Register on September 29, 2010.
For additional information, visit:
Guidance for Industry and Investigators: Safety Reporting Requirements for INDs and BA/BE Studies
Guidance for Industry and Investigators: Safety Reporting Requirements for INDs and BA/BE Studies—Small Entity Compliance Guide

2. Letters to Doctors about Risks of Purchasing Unapproved Versions of Botox and Other Medications from Foreign or Unlicensed Suppliers
The FDA has alerted more than 350 medical practices that they may have received unapproved medications, including unapproved versions of Botox, from a foreign supplier. These medications may be counterfeit, contaminated, improperly stored and transported, ineffective, and/or unsafe. Medical practices that purchase and administer illegal and unapproved medications from foreign sources are placing patients at risk and potentially depriving them of proper treatment.  
To minimize the chance of patients receiving an unapproved, counterfeit, unsafe, or ineffective medication, FDA requests that medical practices stop administering the unapproved versions of Botox and any other products they have received from foreign suppliers owned and operated by Canada Drugs and known under the following names: Quality Specialty Products (QSP), A+ Health Supplies, QP Medical, Bridgewater Medical, or Clinical Care.  Many, if not all, of the products sold and distributed by these suppliers have not been approved by FDA. Therefore, FDA cannot confirm that the manufacture and handling of these products follow U.S. regulations or that these medications are safe and effective for their intended uses.
For additional information, visit: Risks of Purchasing Unapproved Versions of Botox