Regulatory Authority Actions

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.

Both regulatory bodies are working on enhancements to their respective adverse event reporting systems in efforts to increase transparency and safety monitoring of drugs.

Industry and FDA face new fee structures and new challenges in implementing fee initiatives.

Focusing on whether the product meets its defined quality attributes should help one make reasonable, documentable, and defendable risk-based decisions, according to Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

FDA sent a warning letter to Shandong Vianor Biotech Co., Ltd. that claimed the company failed to follow proper data integrity and quality control procedures.

The draft guidance gives recommendations for reproductive toxicity testing and labeling.

The agency will require training for healthcare providers who prescribe immediate-release opioids.

FDA rejected the company’s biologics license application for its anti-rheumatoid arthritis biologic and has requested additional clinical safety data.

FDA participated in a global operation to combat the sale and distribution of unapproved and illegal drugs.

The agency sent out 13 warning letters on Sept. 19, 2017 to companies selling drug products online.

Validation and batch testing failures were among the violations found by the FDA at the company’s Jiangsu facility.

The approval marks the first biosimilar approved in the United States for treating cancers.

European Medicines Agency’s Committee for Medicinal Products for Human Use grants a positive opinion for the approval of the biosimilar for treating breast cancer.

The agency is looking for industry input on best practices for continuous manufacturing.

A new collaboration between CDER and ORA will more fully integrate drug review programs with facility evaluations and inspections, in an effort to streamline drug reviews while strengthening manufacturing oversight.

FDA has put out an alert regarding the risks associated with using Keytruda in combination with other anti-cancer drugs based on interim results from two clinical trials that showed increased risk of death.

Faced with divisive political and social issues, Congress must find a way to reach consensus.

FDA issued a Refusal to File letter to Acorda Therapeutics, citing insufficiently complete information in the company’s new drug application for its investigational Parkinson’s disease drug.

An FDA evaluation concluded that Corden Pharma Latina’s corrective actions addressed the concerns in an FDA warning letter.