Regulatory Oversight and Compliance

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The draft guidance gives recommendations on how certain oral drug products should be labeled regarding gluten.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majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.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.

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.

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.

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

The agency approved Abilify MyCite, a pill with a sensor that digitally tracks if patients have ingested their medication.

Two of the medicines recommended for approval are orphan drugs.

The EMA’s Committee for Medicinal Products for Human Use has recommended marketing authorization approval for AstraZeneca’s benralizumab, a monoclonal antibody for treating severe asthma.

The company expects to commercially launch the new vaccine in the US in the first quarter of 2018.

FDA is exploring ways to keep branded drug companies from using REMS to block the development of generic drugs.