Quality/GMPs

The agency provides a qualified context of use for the biomarker plasma fibrinogen.

FDA sent a warning letter to an Illinois compounding pharmacy for violations of the Federal Food, Drug, and Cosmetic Act.

Concerns have emerged that continued growth in the biosimilars market could be limited by mounting pressure to push down on prescription drug outlays.

The company voluntarily recalled the product due to detached needles on the syringe in the kit.

Mumbai, the location for its new Indian subsidiary, will also be the site for the company's Uniquity Global Conference on October 6, 2016.

The Indian facility was cited for a range of quality and data integrity violations.

The agency published a guideline for the implementation of ICH Q3D.

FDA issued a warning letter to Lima & Pergher Industria e Comercio S/A for CGMP violations.

Regulatory agencies meet to discuss approaches to the development of antibacterial agents.

Airlines, airports, freight forwarders, and other cold-chain partners are taking a crash course in pharma cGMPs.

Innovations in electrophoresis and chromatography upstream of protein characterization can accelerate research.

Manufacturers and regulatory authorities seek coordinated lifecycle management policies.

FDA cites two Xinxiang Tuoxin Biochemical facilities with CGMP deviations.

Sandoz won FDA approval for its biosimilar version of Enbrel.

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

The new guidance addresses FDA refuse-to-receive decisions in regards to impurity limits.

FDA issued a warning letter to the company for quality control violations.

The agency sent a warning letter to Cape Apothecary for adulterated drugs.

FDA issued a warning letter to College Pharmacy for multiple violations.

The Parenteral Drug Association develops program to address barriers to implementation of postapproval changes.

The debate over who has control over patents for CRISPR gene-editing technology came to a head on August 17, 2016 after an email was released from a former graduate student at the Broad Institute accusing Harvard-MIT of wrongfully securing patents to the technology.

The company is voluntarily recalling one lot of Oxacillin for Injection, USP, 10 g.

The Chinese facility was cited for data integrity violations.

Nine public health organizations submitted a letter to members of US House and Senate committees citing concerns with FDA’s decision to make changes to a section of the FDA and NIH Workforce Authorities Modernization Act.

The agency has adopted guidelines on the pharmacovigilance of biological drugs.