Regulatory Authority Actions

FDA clarifies GDUFA requirements in regards to abbreviated new drug applications and prior approval supplements.

The European Medicine Agency details the agency?s recommendations for drug-marketing authorizations for the first half of 2014.

Several groups, including pharmacies, call on FDA to preserve accepted International Nonproprietary Name conventions for biosimilars.

FDA draft guidances seek to maintain accurate drug information in new media.

European Medicines Agency clarifies advanced-therapy medicinal products classification.

FDA releases guidance documents and rules on requirements for compounding human drug products.

Stakeholders face challenges and benefits from a more secure pharmaceutical supply chain.

GSK Biologicals receives warning about cGMP compliance issues at its Quebec facility.

FDA cites cGMP violations for API manufacturing at a facility in Tianjin, China.

EDQM details the agency?s accomplishments in 2013.

FDA inspection found cGMP violations in the Bangalore, India API manufacturing facility.

FDA issues guidance on the use of social media in regards to prescription drugs.

ISPE Metrics Pilot Program is designed to demonstrate the feasibility and value of standard quality metrics.

FDA provides advice to supply-chain stakeholders on how to identify suspect drug products and how to notify the agency of those products.

Draft guidance from FDA includes information essential for the completion of ANDA applications.

EMA publishes revised guideline on the acceptability of names for drugs.

FDA issues a Form 483 to Wockhardt for quality issues at Morton Grove, IL facility.

FDA launches openFDA to provide easy access to FDA public data.

The European Pharmacopoeia Commission re-evaluates its policy on the development of monographs for finished drug products.

FDA finalizes guidance on expedited programs for new drug approvals for treatment of serious and life-threatening conditions.

EMA opens registration for it's sixth annual workshop on pediatric drug research and development.

FDA and EMA release a draft joint proposal on the development of new drugs to treat Gaucher disease in children.

FDA clarifies stability data recommendations for abbreviated new drug applications.

Draft guidance addresses the use of clinical pharmacology studies to determine biosimilarity of biologics.

FDA releases draft guidance on the development of drugs to treat hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia.