Regulatory Authority Actions

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The agency revised draft guidance to enable more efficient and successful drug development programs for the treatment or prevention of rare diseases.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

The agency sent a warning letter to Cao Medical Equipment Co., Ltd. after inspectors found CGMP violations at the company’s Langfang, Hebei facility.

FDA has withdrawn the proposed rule that would have allowed generic-drug makers to independently update and distribute new safety information in drug labels.

FDA cites Zhejiang Huahai Pharmaceutical in valsartan impurity investigation.

New FDA guidance developed to identify lapses in data integrity and promote best practices.

The agency is looking to leverage real-world health data to support drug development.

FDA has approved Truxima (rituximab-abbs), a biosimilar to Roche’s anti-cancer biologic, Rituxan (rituximab).

The proposal from the Centers for Medicare and Medicaid Services (CMS) proposes to give plans more flexibility to limit coverage of certain drugs.

A required time frame should not be the driving force behind root cause investigations, says Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates.

Despite ongoing efforts to address the problem, FDA now sees a rise in active shortages and in the duration of supply problems.

The positive opinions included the first oral-only tablet for the treatment of human African trypanosomiasis.

The agency provided an update on its relocation plans and assured that core activities are continuing uninterrupted.

The new good pharmacovigilance practice chapter IV on specific considerations for the pediatric population offers a holistic view of pediatric pharmacovigilance and provides guidance on how to address the specific needs and challenges of safety monitoring of medicines used in children.

The agency sent a warning letter to the company for marketing an unapproved stem cell product and CGMP violations.

The agency is developing a new way to assess, record, and report data from surveillance and preapproval inspections of sterile drugs.

Leaders of the two parties are open to challenging the status quo on drug costs and spending.