FDA finalizes updated guidance for industry outlining current recommendations for demonstrating bioequivalence of generic topical dermatologic corticosteroids, replacing a policy that had been in place since 1995.
The agency posts a final guidance that provides recommendations for formal meetings between the agency and sponsors or requestors developing over-the-counter monograph drugs.
FDA finalizes updated guidance for industry outlining current recommendations for demonstrating bioequivalence of generic topical dermatologic corticosteroids, replacing a policy that had been in place since 1995.
The agency posts a final guidance that provides recommendations for formal meetings between the agency and sponsors or requestors developing over-the-counter monograph drugs.
The House Energy and Commerce Subcommittee on Health plans a hearing 7/15 to examine how FDA can help strengthen U.S. leadership in biomedical innovation amid growing concerns that early-stage drug development is increasingly shifting overseas.
DTC Perspectives CEO Bob Ehrlich warns that an upcoming FDA proposal to eliminate the adequate provision standard could amount to a de facto ban on branded television drug advertisements.
