Regulatory Oversight and Compliance

A Federal circuit appeals court ruled that a biosimilar manufacturer will have to wait 6 months after FDA approval to commercially launch its medication.

Baxter has initiated a voluntary recall of two lots of IV solutions due to the potential presence of particulate matter.

A year-long process reauthorizing the Prescription Drug User Fee Act was launched July 15, 2015 with a public meeting, setting the stage for discussions with industry and FDA.

FDA releases a report that analyses why some diseases are lacking treatment options.

The agency has released guidance on bioequivalence studies for asenapine, prasugrel, sitagliptin, and zonisamide.

FDA released news of the ban of Emcure’s Hinjewadi manufacturing plant after it determined the plant did not meet basic quality standards.

The agency requires early notification of potential drug shortages.

The European Medicines Agency reviews the safety of human papillomavirus vaccines.

The International Conference on Harmonization has moved ICH M7(R1) Addendum to 3 of the ICH process.

A study now underway on vaccine manufacturing examines the effects of focusing on consistency during manufacturing, instead of post-production testing.

FDA orders unapproved prescription ear drop products with active ingredients removed from the market.

The amendment suggests modifications to the calculation of a drug's average manufacturing price and to the reimbursement rate for infused medications.

Manufacturers and FDA look for innovative strategies to meet accelerated timeframes.

The European Union has a challenging task ahead as it strives to harmonize regulations on advanced therapy medicinal products.

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to handle internal audit reports during inspections.

Heightened regulatory scrutiny of data integrity highlights the need for comprehensive procedural reviews and strategies for managing mission-critical information.

US Court orders New Jersey drug manufacturer and its president to stop distribution of unapproved and misbranded drugs.

An ISPE guidance document, four years in the making, brings risk-based thinking, statistics, and Lean Six Sigma to cleaning validation.

Sue Schniepp, Chair, PDA Regulatory and Quality Advisory Board, and Hal Basemen, Chair, PDA, spoke with Pharmaceutical Technology about resolving drug shortages.

The agency gives a limited reprieve to dispensers but requires other trading partners to provide product tracing information.

A recent Ernst & Young survey highlights the challenges facing Indian pharma

Pharmacy associates say more education regarding the transactional requirements of DSCSA is needed.

The agency clarifies its requirements for allowable excess volume and labeled vial fill size in injectables and biologics.

The agency takes action against websites that illegally sell unapproved medications.

NIH provides an interim corrective action plan to correct deficiencies found in its Clinical Center Pharmaceutical Development Section.

The agency streamlines risk and mitigation information.

The agency publishes guidance on the physical attributes of generic tablets and capsules.

Presenters at IVT's Microbiology Week discussed best practices and recent guidance publications for microbial control in sterile and non-sterile pharmaceutical processes.

The agency creates initiative to stimulate pediatric drug development.

An FDA advisory panel voted 13-3 in favor of approval of Sanofi and Regeneron Pharmaceuticals' cholesterol-homeostasis therapy Praluent (alirocumab).