Quality Systems

Implementation of the Packaging Serialization Standard cuts serialization costs, shortens deployment time, and expedites compliance with anticounterfeiting regulations.

New tax legislation may result in savings for biopharma companies.

The company is voluntarily recalling one lot of Pantoprazole Sodium for Injection 40 mg per vial because of glass particles found in a vial.

FDA has approved a new gene therapy for treating patients born with a rare, inherited vision loss.

FDA sent a warning letter to Deserving Health International Corp. after inspectors found CGMP violations including failure to prevent microbiological contamination.

Sanofi Genzyme and its partner, Alnylam Pharmaceuticals, have filed a marketing authorization application with EMA for an investigational RNAi therapeutic for treating a genetic-based disease.

EMA recommends suspending the marketing of modified- or prolonged-released products containing paracetamol due to a difficulty in managing overdose.

The European Commission has closed its infringement procedure against Roche after the company completed remedial actions.

The draft guidance provides guidance on the development of drugs and biologics in which a nanomaterial is present in the finished dosage form.

The agency has proposed a risk-based enforcement approach to protecting patients against unproven homeopathic drugs.

The agency published guidance on the research and development of individualized therapies.

The company is seeking approval from FDA for use of the drug, migalastat, to treat Fabry disease in patients who have amenable mutations.

FDA has approved a Pfizer biosimilar to J&J’s top-selling anti-inflammatory biologic, Remicade.

The draft guidance gives recommendations on how certain oral drug products should be labeled regarding gluten.

The approval for Admelog (insulin lispro injection) marks the first short-acting insulin approved as a “follow-on” product.

The European Medicines Agency has granted Samsung BioLogics approval to manufacture a monoclonal antibody at the company’s second facility in Songdo, Incheon, South Korea.

The agency has posted a warning letter to companies promoting Coco Loko, a snortable chocolate powder, and Legal Lean, a drink, as substitutes for street drugs.

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.