Regulatory Authority Actions

The debate continues over biosimilar naming, interchangeability, and patent protection, as well as lingering concerns in the medical community about the safety of switching patients to new therapies.

While most pharma companies are in partial production using generators, few are operating at 100% capacity.

The voluntary recall is due to blister packages containing the incorrect product.

The agency gave Breakthrough Therapy Designation to GSK’s GSK2857916 monotherapy for the treatment of patients with multiple myeloma who have failed at least three prior lines of therapy.

FDA sent warning letters to four companies illegally selling products online that claim to prevent, diagnose, treat, or cure cancer without evidence to support these statements.

Siegfried Schmitt, PhD, principal consultant, PAREXEL, discusses how to prepare for an inspection by a foreign regulatory agency.

FDA seeks to focus on problematic facilities and inform firms quickly about site problems.

The level of formality in change control may be holding back your SOP progress, according to Siegfried Schmitt, principal consultant at PAREXEL.

A mutual recognition agreement to accept inspection data from eight EU regulatory authorities may reduce inspection burdens at global drug facilities.

The vaccine is approved for the prevention of shingles in adult patients aged 50 years and older.

FDA sent a warning letter to Ridge Properties, LLC, after inspectors found a variety of current good manufacturing practice violations at the company’s Salem, OR facility.

Scott Gottlieb, MD, went before the House Committee on Energy and Commerce to give members the agency’s view on how to fight the opioid crisis, stressing the use of long-term treatment with drug therapy.

The M&A advisory firm has developed an interactive map of manufacturing sites to give insight into the market size of global manufacturing.

The agency has published educational material for physicians promoting the benefits of biosimilars.

This approval marks the second gene therapy to be approved by FDA and the first to be approved for certain types of non-Hodgkin lymphoma.

The vaccine is a non-live, recombinant subunit vaccine that combines an antigen and an adjuvant system to trigger a targeted and long-lasting immune response to the shingle-causing virus.

Stelara (ustekinumab), already approved for treating adults, is now also approved for treating adolescents with moderate to severe plaque psoriasis.

The committee has voted unanimously to approve Spark Therapeutics’ gene therapy candidate, Luxturna (voretigene neparvovec), for treating a genetically inherited blindness.

Amgen is seeking approval for an additional indication in glucocorticoid-induced osteoporosis for its blockbuster osteoporosis therapeutic, Prolia.

AstraZeneca is seeking approval for its anti-cancer monoclonal antibody, Imfinzi, for treating non-small cell lung cancer in the European Union.

Europe updates the guideline on excipients information in labeling and packaging.

The agency published guidance on developing antiviral drugs to treat respiratory syncytial virus infection.

The guidance gives recommendations for resolving scientific or regulatory issues with FDA regarding ANDA applications.

FDA published guidance on the format and content of REMS documents.

FDA and manufacturers strive to prevent drug shortages from Hurricane Maria.