Regulatory Authority Actions

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.

The agency published four guidance documents regarding ANDAs and amendments to ANDAs.

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

Just as FDA strengthens ties between reviewers and plant inspectors, proactive manufacturers are involving different disciplines in preparation for FDA audits.

The draft guidance gives recommendations for reproductive toxicity testing and labeling.

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

The FDA commissioner made a statement about the agency’s efforts to ensure patient access to safe compounded medicines.

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

FDA cited Meridian Medical Technologies, a Pfizer company, which manufactures Mylan’s EpiPen, for cGMP violations that included failure to appropriately investigate defects in auto-injector components.

Pfizer’s Mylotarg, an anti-body drug conjugate once voluntarily withdrawn, returns to the market under a new dosing regimen for treating leukemia.

FDA works with industry on strategies for assuring high-quality regenerative medicines.

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.

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.

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

High-priority issues requiring immediate attention leave little time for Congress to consider drug access proposals that have limited bipartisan support.

FDA halts unproved stem-cell cancer treatments administered to California patients, which was derived from a commercially unavailable military-grade vaccine.

FDA issues a statement on new policy and enforcement steps to ensure proper oversight of stem cell therapies and regenerative medicine in the wake of two incidents involving unauthorized stem-cell treatment activity.

FDA has signed a confidentiality commitment with the European Commission and the European Medicines Agency that allows FDA to share confidential information with EU regulations.

FDA sent a warning letter to Bicooya Cosmetics Limited after inspectors found rodent feces at the company’s Zhejiang, China facility.

A meeting of the Pediatric Advisory Committee will advise on the use of prescription opioid medications containing hydrocodone or codeine in children’s cough medicine.

The directors of FDA’s Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health praised Congress’ reauthorization of user fee programs.

The agency published guidance on identifying trading partners under DSCSA.