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This Week at FDA: HHS vaccine injury initiative, midterms could reshape congressional committees overseeing FDA, and more

Fri, 09 Oct 2026 00:00:00 +0000

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, the Department of Health and Human Services (HHS) announced an agency-wide initiative to study and address vaccine injuries, and the congressional committees that oversee FDA could see high turnover after the midterm elections.

Study: Growing patent thickets may hinder generic competition

Fri, 09 Oct 2026 00:00:00 +0000

Over the last 15 years, there has been an uptick in the number of patents associated with small-molecule drugs approved by the US Food and Drug Administration (FDA), with a majority of the increase linked to the use of non-primary patents, according to the results of a recent special communication published in JAMA.

Experts weigh in on FDA’s transparency roadmap

Thu, 08 Oct 2026 00:00:00 +0000

The US Food and Drug Administration (FDA) recently released a transparency roadmap outlining its achievements in FY 2026 and its priorities for FY 2027. Two key priorities for the future include a proposal to require public disclosure of new drug applications (NDAs) and biologics license applications (BLAs) upon filing, as well as proactively publishing all inspection reports.

Euro Roundup: European Commission calls for EMA to urgently advance Biotech Act preparations

Thu, 08 Oct 2026 00:00:00 +0000

The European Commission has set out the need for the European Medicines Agency (EMA) to urgently advance preparations for the Biotech Act.

Recon: FDA identifies four deaths in Newron schizophrenia drug trials; Dutch court blocks subcutaneous Keytruda in eight Europea...

Thu, 08 Oct 2026 00:00:00 +0000

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

EMA plans major update to pharmacogenomics guideline

Wed, 07 Oct 2026 00:00:00 +0000

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) is planning to update a 2018 guideline on good pharmacogenomic practices. While the guideline is less than a decade old, the pace of change in pharmacogenomics has prompted regulators to revisit their recommendations.

MHRA adopts AI framework proposed by UK docs

Tue, 06 Oct 2026 00:00:00 +0000

The Medicines and Healthcare products Regulatory Agency (MHRA) says the UK government has adopted a list of recommendations on the use of artificial intelligence (AI) in medical devices developed by an independent group of doctors in the National Health Service (NHS). The agency also said it is initiating the third phase of its AI Airlock, a regulatory sandbox for evaluating new AI products.

WHO drafts updated guideline on quality risk management

Tue, 06 Oct 2026 00:00:00 +0000

The World Health Organization (WHO) has issued an updated draft guideline to assist manufacturers establish an effective quality risk management (QRM) system and to help regulators in planning their inspections. The guidance incorporates concepts from the International Council for Harmonization’s (ICH) Q9 (R1) guideline on quality risk management (QRM).

Recon: BD pledges $19B US investment; McKesson, CD&R to buy Option Care for $5.8B

Tue, 06 Oct 2026 00:00:00 +0000

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.