The Pharma Letter13h
US FDA issues more warning letters to Asian producers
The US Food and Drug Administration (FDA) has issued several warning letters to pharmaceutical manufacturers in India and ...
FDA spars with Texas company over ‘unapproved’ and ‘unlicensed’ human amniotic products
Federal regulators have warned a Waco, Texas, company that its human amniotic products are “unlicensed” and “unapproved,” and ...
STAT14h
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 ...
JD Supra23d
Complete Response Letter, Warning Letter and Shareholder Lawsuit Follow FDA Data Integrity Findings
Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 Warning Letter 1 from the US Food and Drug Administration ...
Food Safety News4d
FDA warns seafood companies over HACCP violations and potentially adulterated products
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its ...
Acsh.org10d
FDA Warning Letter
The crisis is long over, but if you were a young family with babies three years ago, scary memories of escalating health worries and retail stores bereft of infant formulas remain.
Food Safety News11d
FDA warns bakery for food safety violations, including sanitation and allergen control failures
As part of its enforcement activities, the Food and Drug Administration (FDA) sends warning letters to entities under its ...
Amid recalls, Minnesota medtech exec says she was pressured to disregard safety law
Susan Krause of Rosemount alleges New Jersey-based Integra LifeSciences pressured her to lie to regulators. Integra says ...
Becker's Hospital Review8d
FDA warns GLP-1 compounder over safety rules
The FDA issued a warning letter to ProRx, a compounding facility in Exton, Penn., after an inspection raised serious concerns regarding the safety and compliance of its drug products. The facility, ...