Articles by Angie Drakulich - Pharmaceutical Technology

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Articles by Angie Drakulich

FDA Office of Compliance to Become a Super Office

Jun 7, 2011

CDER Director Janet Woodcock announces reorganization.

Global Healthcare on the Ground: BIO and BIO Ventures for Global Health

A Focus on Creative Strategies to Help the Developing World.
Jun 2, 2011

A Focus on Creative Strategies to Help the Developing World.

FDA Approvals of Biopharmaceuticals on the Rise

May 19, 2011

Regulatory approvals for new biopharmaceuticals in the United States have nearly doubled in the past decade compared with the 1990s, says a Tufts study.

FDA to Study Online Drug Marketing

May 5, 2011

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.

Up Close and Personal

Regulators and standard-setting bodies are re-examining over-the-counter drugs.
May 2, 2011

Regulators and standard-setting bodies are re-examining over-the-counter drugs.

FDA Issues Draft Guidance on User-Fee Waivers, Reductions, and Refunds

Mar 17, 2011

FDA issued a draft guidance for industry on Mar. 11, 2011, titled User Fee Waivers, Reductions, and Refunds for Drug and Biological Products, that offers recommendations to applicants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 A similar draft guidance was issued in July 1993.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.

FDA Removes from Market Unapproved Cough and Cold Prescription Products

Mar 3, 2011

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.

Is Facebook the Place for FDA?

Social media tools have taken over many aspects of our lives, now including regulatory info.
Mar 2, 2011

Social media tools have taken over many aspects of our lives, now including regulatory info.

USP Moves Drug Quality Pilot Program into Sub-Saharan Africa

Feb 10, 2011

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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Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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