This month, FDA released the latest in a series of agency guidance to advance the development and use of real-world data (RWD) and real-world evidence (RWE) in clinical trial designs for drug development programs. The draft...more
On November 9, FDA Commissioner Scott Gottlieb, M.D., announced that the agency launched new inspection protocols for aseptic processing of sterile drugs to be used by FDA investigators during surveillance and pre-approval...more
Earlier yesterday, FDA Commissioner Scott Gottlieb, M.D., made publicly available for the first time FDA’s internal policy (MAPP 5014.1) for how drug manufacturing facilities are prioritized and scheduled for surveillance...more
On Wednesday, FDA announced that it filed two complaints in federal court seeking injunctions to stop marketing efforts of unapproved stem cell treatments by US Stem Cell Clinic of Sunrise, Florida, and California Stem Cell...more
5/14/2018
/ Commercial Marketing ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Injunctions ,
Life Sciences ,
Patient Safety ,
Pharmaceutical Industry ,
Regenerative Medicine ,
Regulatory Oversight ,
Regulatory Standards ,
Stem cells
Last week, the U.S. Food and Drug Administration (FDA) announced a comprehensive framework for development and oversight of regenerative medicine products, including innovative cell-based therapies. ...more
Earlier yesterday, FDA announced that it has determined that the regulatory authorities of Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom are “capable of conducting inspections of...more
11/1/2017
/ Confidential Information ,
EU ,
Food and Drug Administration (FDA) ,
Inspections ,
Intellectual Property Protection ,
Mutual Recognition Agreement ,
Non-Public Information ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agencies ,
Regulatory Oversight ,
Trade Secrets
FDA recently launched a public dashboard within the FDA’s Adverse Event Reporting System (FAERS) to improve access to data on adverse events related to drug and biological products. FDA Commissioner Scott Gottlieb, M.D....more
The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the European Commission – DG Sante (DG Sante), signed a new confidentiality commitment which expands the scope of the current...more