Federal Register final order: FDA exempts from premarket notification requirements autosomal recessive carrier screening gene mutation detection syste...
FDA denies a Millennial Pharmaceuticals petition seeking to put limits on ANDA or 505(b)(2) applications referencing its Velcade.
FDA Oncology Center of Excellence staffers say they are optimistic about the future of oncology drug development after approving the first site-agnost...
FDA lifts its clinical hold on a Cellectis investigational cancer drugs Phase 1 trials.
FDA releases its latest batch of Warning Letters that includes Biomin Industries and Guangdong Zhanjiang Jimin Pharmaceutical Co.
A JAMA viewpoint piece urges medical journal editors to encourage study authors to disclose CDRHs role in clinical trial design and execution and to d...
FDA posts a guidance on Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery.
FDA releases a guidance on Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment.