Regulatory Authority Actions

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The agency revised draft guidance to enable more efficient and successful drug development programs for the treatment or prevention of rare diseases.

Industry investment and regulatory support combined to move many important new medicines to market.

Sanofi’s Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis [Tdap] vaccine adsorbed) is approved for a repeat dose in people 10 through 64 years of age, 8 years or more after the first vaccination.

The revised guidance aims to strengthen the agency’s global approach to develop new antibacterial medicines.

Orphan and cancer drugs continue to lead, but treatments for many common diseases were also approved in 2018.

The plan details five goals to guide the development of Sentinel, a national electronic system for medical product safety surveillance established as part of the FDA Amendments Act of 2007, over the next five years.

In 2018, the agency authorized 42 drugs with new active substances, three advanced therapies, and 21 orphan drugs.

FDA sent a warning letter to Skylark CMC Pvt. Ltd. after employees refused to let agency inspectors enter the company’s Ahmedabad, Gujarat, India facility.

Pricing pressures, investment volatility, and government disfunction greet Biopharma in 2019.

Core functions and those funded by fiscal year 2018 user fees are continuing, and 59% of the agency’s staffers are being retained.

The agency sent a warning letter to Roche’s Genetech for marketing unapproved stem cell products and puts other stem cell firms and providers on notice.