CDER director Janet Woodcock says two recent drug approvals demonstrate a bright future for precision medicine.
The Washington Legal Foundation asks the 4th Circuit Court of Appeals to uphold a federal district court ruling granting summary judgment to Pfizer in...
A Friends of Cancer Research statement calls on Congress to broaden FDAs authority to encourage drug companies to develop a mechanism to more readily ...
FDA releases an FDA-483 with 11 inspection observations from Chinas Zhejiang Bangli Medical Products.
Attorney Eric Miller says in a WLF Legal Opinion Letter that the Washington Supreme Court is unreasonably expanding product liability law to require m...
GAO says FDA and stakeholders have taken steps to improve the agencys expanded access program to improve patient access to drugs.
FDA abandons a requirement imposed on Amicus Therapeutics to conduct an additional Phase 3 study to assess Gastrointestinal symptoms with its oral pre...
FDA releases its latest batch of Warning Letters that includes New Capstone and Vista Pharmaceuticals.