FDA Gives (Gentle) Nudge to Industry on Stem Cells
The FDA is giving a gentle but clear nudge to industry on stem cells with a new rapid-response program to help regenerative medicine makers to get on the right side…
Warning Letter Roundup: FDA Scolds Drugmakers for Quality Violations
The FDA hit two U.S. and one Taiwanese drugmaker for a variety of shortcomings at their facilities, including quality oversight, inadequate testing and faulty equipment. Source: Drug GMP Report
FDA Criticizes California Drugmaker for Prescription Diet Pill Claims
The FDA’s ad police warned a Campbell, Calif.-based company to stop claiming that its prescription diet pill can help patients lose weight three times faster than diet and exercise alone.…
CDER’s Office of Compliance to Lead Compounder Regulation
As part of its ongoing enforcement efforts against drug compounders, the FDA plans to move the program’s base of operations from CDER’s Office of the Center Director to the Office…
House Appropriations Pushes FDA on Continuous Manufacturing
The House Appropriations committee approved nearly $3.3 billion in spending for the FDA for fiscal year 2020 and once again nudged the agency to get going on its delayed continuous…
Glenmark Draws Complete Response Letter for Allergy Spray
Glenmark Pharmaceuticals said it is “confident” that it can get its investigational allergy spray Ryaltris back on track after the FDA pulled the brakes on its application in the form…
Congress Seeks GAO Review of Foreign Drug Inspection Program
Ongoing recalls of contaminated blood pressure drugs prompted the House Energy and Commerce Committee to call on Friday for a review of the FDA’s foreign drug inspection program. Source: Drug…
FDA Issues Guidance on Developing Drugs to Treat Epidermolysis Bullosa
The FDA released final guidance for sponsors of drugs to treat or prevent serious flare-ups of skin disorders known collectively as epidermolysis bullosa (EB). Source: Drug Industry Daily
Pfizer Bags a New Biosimilar — and a Former Commissioner
In a big week for Pfizer, the world’s second largest drugmaker earned the FDA’s approval for a biosimilar cancer treatment and signed up the agency’s former Commissioner Scott Gottlieb for…
CBER Flags Planned Gene Therapy Guidances for 2019
CBER released an updated list of guidances it plans to publish this year, including draft recommendations on the following gene therapy topics: Source: Drug Industry Daily
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