An NIH Covid-19 treatment guideline panel refutes FDAs recent decision to grant an Emergency Use Authorization (EUA) for convalescent plasma for treat...
Mylan recalls four lots of amiodarone HCl injection, USP 450 mg/9 mL, and tranexamic acid injection, USP 1000 mg/10 mL due to potential labeling mix-u...
FDA warns Mylan about CGMP deviations in producing active pharmaceutical ingredients at one of its facilities in India.
FDA warns Acella Pharmaceuticals about CGMP and other violations in its production of finished drugs.
Two drug company stakeholders respond to an FDA draft guidance on Orange Book questions and answers.
Attorney Jeffrey Shapiro discusses reasons why HHS made the right decision in ordering FDA to abstain from the premarket review of laboratory-develope...
FDA releases its latest batch of Warning Letters that includes Acella Pharmaceuticals, Mylan and Revival Products.
An assessment finds that combination product review practices are generally efficient and effective and need only minor adjustments.