Regulatory Oversight and Compliance

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.

CPhI released the findings of the 2017 India Pharma Market Report, which identified a two-tier manufacturing market and forecasted increased acquisitions by Indian companies, along with a significant improvement in the international reputation of Indian-made pharmaceuticals.

A pilot program will offer instruction on scientific and regulatory guidelines including training on GMPs and quality.

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 China Food and Drug Administration has submitted its membership to the International Council for Harmonization.

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

Following passage by the House in July 2017, the Senate has voted to pass a reauthorization bill for FDA user-fee programs for drugs and medical devices ahead of the user-fee programs’ expiration date.

FDA urges manufacturers to seek fast approval of “high-need” generics and targeted therapies. 

The review of batch records creates a story of the materials, manufacturing, and packaging involved in the production of bio/pharmaceuticals, according to Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.

FDA’s Emerging Technologies Team (ETT) team chair Sau Lee describes the reasons for the team and its structure.

The author describes how to establish acceptance limits for acceptance value (AV) data for process validation batches, typical characteristics of AV distributions, and how to derive relevant constants for AV control charts in annual product review and continued process verification reports.

EMA recognizes the need to provide more assistance and guidance to SMEs developing new medicines and applying for marketing authorizations.

The agency is asking for comments on a reflection paper on developing drugs for the needs of older patients.

The agency has developed a business continuity plan to ensure that the public’s health is protected during the agency’s relocation.

Research suggests that on-site audits are becoming less meaningful because suppliers are less willing to devote time to them.

Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.

Manufacturers are seeking greater oversight of how providers reimburse for and dispense covered drugs.