Regulatory Oversight and Compliance

The draft guidance gives recommendations for reproductive toxicity testing and labeling.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

Biopharmaceutical companies developing new competitive biotech therapies have pressed hard for clarity on the testing and data required by FDA to gain market approval of biosimilars that can be filled by a pharmacist without prescriber preapproval.

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.

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Pfizer’s Mylotarg, an anti-body drug conjugate once voluntarily withdrawn, returns to the market under a new dosing regimen for treating leukemia.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

EMA recognizes that a regulatory framework, under which medicines and diagnostics are developed and approved independently, may not be ideal.

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.

FDA sent a warning letter to Maple Rose Enterprises, Inc., dba Pencol Compounding Pharmacy, citing the company for violations of sterile manufacturing practices.

The agency sent a warning letter to Cellex-C International regarding GMP violations found at the company’s Toronto facility.

Efforts to establish an international system for identifying and tracing drugs through the global supply chain are moving forward.

The Senate voted 94–1 to approve legislation reauthorizing user fees and a series of program changes.