Regulatory Oversight

EMA’s revised guideline on the implementation of accelerated assessment is open for public consultation.

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

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

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

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.

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.

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.

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

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

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

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.

The agency issues draft guidance on the development of drugs to treat Duchenne muscular dystrophy.

FDA recently issued a much-anticipated draft guidance on how to define and report established conditions in market applications.

Agency officials visit China to meet with Chinese regulators and industry representatives about keeping the pharma supply chain safe.

Drug quality issues have forced the National Institutes of Health to shutter its in-house facility for producing clinical supplies for certain clinical trials.

FDA cites 17 observations including air handling, quality control, and deficient microbial monitoring at NIH’s Clinical Center Pharmaceutical Development Section.

Clearly defined zones of cleanliness must be designed and maintained to prevent product contamination.

The draft guidance document clarifies chemistry, manufacturing, and controls information for marketing applications.

New guidance complements ICH guidelines on impurities.

FDA issues a Form 483 following inspection of Impax Laboratories' Hayward, CA facility.

FDA cites Yunnan Hande Bio-Tech for cGMP violations related to data collection and security.

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to keep up with changing regulations.

Pharma can boast of big-picture successes, but needs to work on operational issues.

The revised "21st Century Cures” proposal includes provisions for research for continuous manufacturing, biomarker development, and NIH funding.