Regulatory Authority Actions

The draft guidance addresses the agency’s policy on evaluating bulk drug substances in drug compounding.

The agency’s Clinical Data Summary Pilot program will post redacted Clinical Study Reports in order to help stakeholders understand why FDA approved a new drug application.

The agency sent a warning letter to Malladi Drugs & Pharmaceuticals Limited after an inspection found CGMP violations that included the presence of vermin.

The agency published two new guidance documents detailing postmarketing safety reporting requirements for combination products.

The European Medicines Agency has published a new tool that gives a transparent overview of the agency’s relocation to Amsterdam.

The agency announced proposed research studies on how healthcare providers and patients understand drug promotional materials.

Revisions to chapters on glass containers and elastomeric closures were canceled following review of comments.

The European Medicines Agency has called for the immediate suspension and recall of AbbVie and Biogen's multiple sclerosis drug Zinbryta (daclizumab beta).

The FDA commissioner outlined the agency's initiatives to reward innovation and biosimilars development.

The agency has approved a new HIV treatment for patients with "limited treatment options".

Manufacturers face demands for timely information on clinical studies, product recalls, and approvals.

FDA enforcement efforts and drug approvals trend upward.

Biologic new molecular entities (NMEs) accounted for 26% of total NME approvals in 2017.

The agency released draft guidance on the format for electronic submissions of NDA and BLA content regarding the planning of bioresearch monitoring inspections.

The agency has approved a new treatment for a certain type of prostate cancer using novel clinical trial endpoint.

FDA Commissioner Scott Gottlieb issued a statement that FDA will be modernizing regulatory programs in order to advance novel treatments.

The Trump budget boosts funding for FDA but squeezes resources for NIH and healthcare.

FDA sent a warning letter to Celltrion detailing CGMP violations, including poor microbial contamination control.

Gottlieb promoted the development of biosimilars and safer opioid packaging at a briefing sponsored by Alliance for a Stronger FDA and the Pew Charitable Trusts.

The agency met to discuss its new temporary and permanent premises in Amsterdam.

The guidance addresses the development, analysis, and presentation of microbiology data during antibacterial drug development.

The NECC supervisory pharmacist at the center of the 2012 fungal meningitis outbreak was sentenced to 8 years in prison.

The President described US drug costs as unfair and stated that prices will come down.

FDA Commissioner Scott Gottlieb says FDA is committed to meet the challenges faced by the saline shortage during an aggressive flu season.

Manufacturers tackle regulatory and competitive issues to develop complex therapies and biosimilars.