Regulatory/GMP Compliance

FDA’s Center for Drug Evaluation and Research has published its second annual report on key safety programs and activities.

The new document answers questions regarding implementation of the ICH Q7 guidance on GMPs for APIs.

A new report gives an overview of the work of the International API Inspection Program.

FDA sent a warning letter to Tris Pharma Inc. after investigators found the company had failed to properly investigate batch failures and establish quality control procedures.

Celltrion received complete response letters from FDA for its rituximab and trastuzumab biosimilars.

The European Pharmacopoeia Commission added 19 new monographs and three new chapters and revised 51 monographs and 15 chapters.

RGtimeline/Shutterstock.comParenteral product quality is improving.

Certificates of analysis can be used to monitor the reliability of products and their suppliers, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

Accelerated development of new preventives raises challenges for efficient CMC evaluation and production.

This is the first of a series of three articles about validation and technical transfer in the bio- pharmaceutical industry.

The draft guidance addresses the agency’s policy on evaluating bulk drug substances in drug compounding.

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

Drug manufacturers can improve use of quality agreements in contract manufacturing.

Contract testing organizations can provide bio/pharma companies with a cost-effective way to adapt to new technologies and regulations.

Process validation is an extension of biologics development processes.

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

In-house experts can help select the right systems and suppliers, making validation and compliance easy, says Siegfried Schmitt, principal consultant at PAREXEL.

FDA enforcement efforts and drug approvals trend upward.

The agency released draft guidance on the format for electronic submissions of NDA and BLA content regarding the planning of bioresearch monitoring inspections.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

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

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