FiercePharma1d
FDA slaps China-based API makers with separate warning letters outlining quality, testing shortfalls
A pair of Chinese manufacturers with active pharmaceutical ingredients that were previously shipped to the U.S. | The FDA ...
Food Safety News3d
FDA warns two companies over foreign supplier verification violations
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...
Superbowl Ad Sparks A Healthy Controversy About Medication Safety
The next FDA Commissioner could solve two big problems with one powerful policy: encourage independent testing of both ...
Yahoo19d
FDA Warns Sanofi of Manufacturing Irregularities at Key Facility
23—THURSDAY, Jan. 23, 2025 (HealthDay News) — The U.S. Food and Drug Administration has warned the pharmaceutical company ... On Jan. 15, 2025, a warning letter was sent to Sanofi stating that FDA ...
STAT5d
Lawmakers ask FDA to review Hims’ Super Bowl ad for ‘misleading’ patients
Two senators wrote to the FDA Friday about the Hims Super Bowl ad, which they said misleads patients about compounded weight ...
pharmaphorum6d
The FDA’s Guidance on Labels and Cartons: yet another attack on pharmaceutical trade dress?
What will the new Guidance mean for pharma companies ... To reduce such errors, the FDA seemingly takes a "pro-trade dress" stance by warning against "look-alike" containers and stressing the ...
Reuters22d
FDA warns of serious allergic reactions with some multiple sclerosis drugs
The health regulator is adding a new boxed warning, the FDA's most prominent warning ... is sold by Sandoz (SDZ.S), opens new tab. The companies did not immediately respond to requests for ...
Vertex Pharmaceuticals Shares Gain After FDA Approves Non-Opioid Pain Drug
Shares of Vertex Pharmaceuticals rose after Journavx, the company’s oral non-opioid pain medication, received Food and Drug ...
The Victoria Advocate21d
FDA Warns Sanofi of Manufacturing Irregularities at Key Facility
THURSDAY, Jan. 23, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has warned the pharmaceutical ... 2025, a warning letter was sent to Sanofi stating that FDA inspectors found ...