• Dr. Reddy's racks up more repeat violations at Bachupally formulations plant

Statement from FDA Commissioner Scott Gottlieb, M.D., on new policy to improve access and foster price competition for drugs that face inadequate generic competition

In too many cases, branded drugs that are no longer protected by patents or other exclusivities do not face expected competition. In fact, there are several hundred of such branded drugs that do not have any generic competition. Instances like these may keep prices high and ultimately hurt American patients. 

We’ve been taking new policy steps at the FDA to support downward pressure on drug prices by helping to clear a path for more efficient generic development. In doing so, we know that various factors may influence a manufacturer’s decision to develop and market a generic drug. For example, some drugs may not attract a high level of interest if there is a limited market for them. We also know that some drugs may ...

FDA advances new efforts to promote development of safe and effective regenerative medicine products

Today, the FDA finalized two guidance documents regarding regenerative medicine therapies. Both documents were first issued in draft in November 2017 as part of a suite of guidances that comprised the FDA’s comprehensive regenerative medicine policy framework.

The first final guidance, Evaluation of Devices Used with Regenerative Medicine Advanced Therapies,which is required by the 21st Century Cures Act, clarifies how the FDA will evaluate devices used in the recovery, isolation or delivery of regenerative medicine advanced therapies (RMATs). The guidance specifies that devices intended for use with a specific RMAT may, together with the RMAT, be considered to comprise a combination product.

The second final guidance, Expedited Programs for Regenerative Medicine Therapies for Serious Conditions, describes the expedited programs that may be available to sponsors of regenerative medicine therapies for serious conditions, including the new Regenerative Medicine Advanced Therapy (RMAT) designation created by the 21st Century Cures Act, Priority Review designation andAccelerated Approval. In addition, the guidance describes the regenerative medicine therapies that may be eligible for RMAT designation.