Regulatory Authority Actions

Ned Sharpless is tapped to take on acting commissioner role following Gottlieb’s resignation.

The agency sent a warning letter to ANDAPharm, LLC after inspectors found the company’s cleaning and stability testing procedures were inadequate.

FDA Commissioner Gottlieb released a statement on the agency’s efforts to refine the naming convention for biosimilars to balance competition and to help ensure patient safety.

Gottlieb’s tenure included record new drug approvals and steps taken to curb opioid abuse.

The FDA commissioner plans to leave the agency in April.

FDA expects more than 200 investigational new drug applications for cell and gene therapies by 2020, causing the agency to strengthen its regulatory program.

In a statement, FDA Commissioner Scott Gottlieb laid out the case for the safety and effectiveness of generic drugs compared to brand drugs.

The Swiss Agency for Therapeutic Products has begun entering GMP compliance information in the European Union’s EudraGMDP database.

The agency clarified the process for development programs for regenerative medicine therapies.

The two countries have been included in the mutual recognition agreement between the EU and US for GMP inspections.

The guidance explains the process of applying for competitive generic therapy designation.

A taskforce evaluated the advantage of using Big Data in the evaluation of the benefits versus risks of medications.

The drug is approved in the United States specifically for treating acquired thrombotic thrombocytopenic purpura, a rare blood-clotting disorder.

FDA came away with the largest boost in its annual budget in a decade as part of the final spending package approved by Congress this week.

Supply chain players are eligible to participate in FDA’s pilot program to develop an electronic system for tracking drug products.

The US District Court for the Western District of Pennsylvania entered into a consent decree of permanent injunction against Ranier’s Rx Laboratory Inc., a compounding facility.

The agency recommended six medicines for approval at its January 2019 meeting, including treatments for lung cancer, HIV-1, and autoimmune disorders.

New HHS proposal would remove the current safe harbor protection from the federal Anti-Kickback Statute for rebates or discounts provided to Medicare Part D drug plans and certain state Medicaid programs.

Policies emphasize the importance of ensuring data integrity in the United States and abroad.

In a statement, FDA Commissioner Scott Gottlieb announced the agency’s plans to publish guidance to promote the development of complex generic drugs.

FDA staffers will be hard-pressed to process and review the wave of new drug application submissions in pre-established timeframes for action.

The guidance describes how to develop a REMS Assessment Plan, discusses the impact of REMS on patient access to drugs, and gives recommendations on reporting REMS findings to FDA.

The investigation into the root cause of the NDMA impurity found in API is still ongoing, but the agency believes the impurities may be caused by specific chemicals and reaction conditions in manufacturing processes.

Full commercial launch of the drug is underway in the United States, with Europe to follow.

The agency revised draft guidance to enable more efficient and successful drug development programs for the treatment or prevention of rare diseases.