Quality Systems

The agency has approved Nucala (mepolizumab) to treat Eosinophilic Granulomatosis with Polyangiitis (EGPA) to GlaxoSmithKline. This indication is the first FDA-approved therapy specifically to treat EGPA.

The authors hope to facilitate further collaboration among all the stakeholders for USP OTC Monograph Modernization with the goal of identifying a satisfactory approach for USP, FDA, and industry.

FDA has accepted for review Eli Lilly and Company’s biologic drug candidate that is in development for treating migraine.

An increasing number of warning letters shows that FDA is observing more problems with pharmaceutical contract manufacturing.

The agency and the European Commission published updated guidance to answer questions about Brexit.

During the November meeting of the agency’s Pharmacovigilance Risk Assessment Committee, review of Esmya (ulipristal acetate) was announced as well as warnings about prostate cancer treatments.

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

FDA has approved Mylan’s biosimilar to Roche’s blockbuster anti-cancer biologic, Herceptin.

The European Commission’s effort to relax supplementary protection certificates to help generic-drug makers and biosimilars producers has sparked strong opposition from the research-based pharmaceutical sector.

SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

New gene therapies and combination products require innovative regulatory approaches.

Rinse sample analysis or visual inspection are risk-based approaches that can be correlated to surface cleanliness to replace surface sampling in a biopharmaceutical equipment cleaning process.

A QbD approach can address manufacturing complexities in transdermal patch manufacturing.

Cross-functional reliability rooms identify risk and planning metrics, provide insights for production forecasts, and predict trends and areas for improvement.

In a recently released statement, FDA Commissioner Scott Gottlieb warned of an amino acids supply shortage and gave an update on a saline supply shortage, both due to the impact of hurricanes on Puerto Rican manufacturing facilities.

Experts slam drug prices and endorse government price negotiations and curbs on drug advertising.

Manufacturers and trading partners struggle to meet drug tracking requirements

The new guidelines discuss GMPs and patient protection specific to advanced therapy medicinal products.

The company is recalling product because of microbial contamination.

Understanding what affects a measurement and implementing appropriate procedures will aid weighing accuracy.

Following a vote by member states in favor of Amsterdam as the agency’s new headquarters, the relocation will take place over the next 16 months, with operations expected to start up in March 2019.

The agency has approved a biologic-based new molecular entity for treating hemophilia A and has expanded the indication for a leukemia drug to now treat a common form of non-Hodgkin lymphoma.

Commissioner Scott Gottlieb, MD, outlined a plan to support innovation of regenerative medicines while ensuring public safety.

The company is voluntarily recalling one lot of NEXTERONE 150 mg/100 mL Premixed Injection because of particulate matter found in the solution.

Commissioner Scott Gottlieb issued a statement warning about the risks associated with kratom.