Quality/GMPs

The guidance provides recommendations for submitting analytical procedures and method validation data to FDA.

FDA warns an Arkansas compounding company that it is in violation of the FDCA.

The bill would authorize spending of approximately $8.1 billion on transit projects through 2015 while legislators plan a long-term bill that could have implications for the pharmaceutical industry.

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 EMA, FDA, and EC met to plan collaboration on pharmaceutical drug development and evaluation.

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.

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

The European Pharmacopoeia has incorporated new provisions to encourage the use of in-process quality control methods.

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

The challenges and strategies of assessing and mitigating risk in biopharmaceutical manufacturing are discussed.

Advances in adventitious agent detection methodology are bringing benefits, but more work needs to be done.

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

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

Sue Schniepp, Chair, PDA Regulatory and Quality Advisory Board, and Hal Basemen, Chair, PDA, speak with BioPharm International.

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

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

The US Pharmacopeial Convention hosts compliance seminar at CPhI China 2015.

The International Conference on Harmonization Steering Committee appoints Dr. Dawn Ronan as the new director of the ICH Secretariat.

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.