Jun 7, 2011
By:
Angie Drakulich
CDER Director Janet Woodcock announces reorganization.
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A Focus on Creative Strategies to Help the Developing World.
Jun 2, 2011
By:
Christina I. Ortiz, Angie Drakulich
A Focus on Creative Strategies to Help the Developing World.
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May 19, 2011
By:
Angie Drakulich
Regulatory approvals for new biopharmaceuticals in the United States have nearly doubled in the past decade compared with the 1990s, says a Tufts study.
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May 5, 2011
By:
Angie Drakulich
FDA is collecting public comments on a series of studies that the agency plans to conduct on online direct-to-consumer promotion of prescription drug products, according to an announcement in the Federal Register.
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Regulators and standard-setting bodies are re-examining over-the-counter drugs.
May 2, 2011
By:
Angie Drakulich
Regulators and standard-setting bodies are re-examining over-the-counter drugs.
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Mar 17, 2011
By:
Angie Drakulich
FDA issued a draft guidance for industry on Mar. 11, 2011, titled User Fee Waivers, Reductions, and Refunds for Drug and Biological Products, that offers recommendations to applicants seeking such actions under the Federal Food, Drug, & Cosmetic Act (FD&C Act). A similar draft guidance was issued in July 1993. The new document clarifies the types of waivers, refunds, and reductions available under the user-fee provisions of the FD&C Act as well as the procedures for handling these requests, including how to appeal an FDA decision.
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Mar 3, 2011
By:
Angie Drakulich
FDA announced on Mar. 2, 2011, that it is taking action against companies that manufacture, distribute, or market certain unapproved prescription oral cough, cold, and allergy products, according to an agency release.
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Social media tools have taken over many aspects of our lives, now including regulatory info.
Mar 2, 2011
By:
Angie Drakulich
Social media tools have taken over many aspects of our lives, now including regulatory info.
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Feb 10, 2011
By:
Angie Drakulich
The United States Pharmacopeial Convention (USP) launched a 12-month pilot Technical Assistance Program (TAP) to provide developing countries in sub-Saharan Africa with greater capacity to test the quality of medicines.
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