Regulatory Focus

FDA official: Patients play an increasing role in rare disease drug development Regulatory News | 01 August 2022 | By Mary Ellen Schneider Patients have a critical role in drug development, from identifying unmet medical needs to assessing meaningful clinical benefits, according to Kerry Jo Lee, MD, associate director of rare diseases in the US Food and Drug Administration’s (FDA) Office of New Drugs (OND).

Califf seeking Congressional assurance user fees won’t run out Regulatory News | 01 August 2022 | By Ferdous Al-Faruque With only two months to go before user fee legislation runs out and no indication Congress will reauthorize it in time, FDA Commissioner Robert Califf sought to assure agency staff that he is doing his best to get certainty from lawmakers their jobs are not in jeopardy, according to a letter to FDA employees dated 29 July.

Asia-Pacific Roundup: TGA focuses on continuous improvement in latest business plan Roundups | 02 August 2022 | By Nick Paul Taylor Australia’s Therapeutic Goods Administration (TGA) has adopted four strategic objectives as part of its business plan for its 2022-23 financial year. The document sets TGA’s product regulation, stakeholder engagement and compliance and innovation agenda for the coming year.

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Recon: CDC says pandemic drove US deaths from antibiotic resistant superbugs; Biden officials mulling expanding second booster to all adults Recon | 12 July 2022 | By Joanne S. Eglovitch 2839 Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Feature Articles | © 3156 Feature articles in June examined food safety in China, US Food and Drug Administration (FDA) guidance on supply chain disruptions, possible updates to the US Dietary Supplement Health and Education Act (DSHEA), and FDA and Federal Trade Commission (FTC) regulation of dietary supplements intended for treating or preventing certain mental health disorders.

Regulatory News 3371 The US Food and Drug Administration (FDA) is modifying the shared Risk Evaluation and Mitigation Strategy (REMS) for mifepristone products to allow women to continue to access the abortion medication through the mail via a certified prescriber. The move, highlighted on FDA’s mifepristone information webpage and in updates to an associated question-and-answer (Q&A) page on 16 December, makes permanent the eased restrictions permitted during the COVID-19 pandemic.

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Regulatory News FDA says IT modernization came at right time for COVID 3008 While the US Food and Drug Administration (FDA) began the process of modernizing its IT systems before the COVID-19 pandemic, the crisis accelerated much of that work and allowed the agency to streamline much of its activities at a critical moment in time, according to FDA Commissioner Robert Califf.

Regulatory News House committee sends FDA budget to floor vote 3021 The US House Appropriations Committee has sent the Food and Drug Administration’s FY2023 funding bill to the full House for a vote. It includes an amendment to stop Russian drugmakers from selling their products in the US to protest the war in Ukraine. On 23 June, the House Appropriations Committee voted 31 to 26, down party lines, to forward a $27.2 billion agriculture budget bill which includes $3.66 billion for FDA in FY2023.