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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 FDA presented its proposed budget to Congress, the agency rejected a petition for a partial 510(k) exemption for certain software products, and former top CDRH officials launched a venture capital firm.

The International Council on Harmonization (ICH) E22 guideline should incorporate caregiver feedback, according to responses submitted by industry groups and manufacturers to a US Food and Drug Administration public consultation.

Many of the bispecific antibodies (BsAbs) approved by global regulators have yet to demonstrate robust clinical benefit beyond surrogate endpoints that led to their initial approval, according to research published in BioDrugs.

US Food and Drug Administration (FDA) officials credited recent advancements in regulatory science and flexibilities with enabling growth in the cell and gene therapy sector during a meeting on Thursday; however, a cell therapy expert said there is still reluctance from FDA and industry to enroll pediatric patients in clinical trials for such treatments.

The US Food and Drug Administration (FDA) has issued a warning letter to a medical spa company in Texas for violating the Drug Supply Chain Security Act (DSCSA) after finding the firm dispensed “significantly more” units of AbbVie’s Botox (onabotulinumtoxinA) than it purchased through legitimate channels.

A European Medicines Agency (EMA) group has recommended actions the regulator and industry can take to accelerate regulatory science research.

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

In the latest meeting minutes released by the US Food and Drug Administration (FDA), the agency noted that significant progress has been made toward an agreement with the pharmaceutical industry for the next Pharmaceutical Drug User Fee Amendments (PDUFA VIII) commitment language.

The US Food and Drug Administration (FDA) has submitted its budget proposal to Congress, outlining its spending priorities for fiscal year 2027. The budget request totals $7.2 billion, including $3.3 billion in appropriations and $3.9 billion in user fees. This request represents an overall increase of approximately $232 million, or 3.3%, compared to the fiscal year 2026 level.

In the latest tranche of published warning letters, the US Food and Drug Administration (FDA) has continued to go after drugmakers for marketing glucagon-like peptide-1 (GLP-1) receptor agonists and similar medications without regulatory approval. It also issued other warning letters for current good manufacturing practices (CGMP) violations and failing to adhere to clinical trial protocols.

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

The US Food and Drug Administration (FDA) has announced that starting on 1 October 2026, manufacturers must submit adverse event individual case safety reports (ICSRs) for drugs, biologics, and combination products using the data standards specified in the International Council for Harmonisation’s (ICH) E2B(R3) guideline.

Several patient and disease advocacy organizations have responded to the Center for Drug Evaluation and Research's (CDER) request for feedback on what it should provide as part of its Learning and Education to ADvance and Empower Rare Disease Drug Developers (LEADER 3D) educational materials.

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

Hong Kong’s Department of Health (DH) has begun a phased transition to the independent assessment of primary data on new drugs submitted for approval in the city.

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, FDA Commissioner Marty Makary reflected on his first year, FDA is reportedly looking to drop peptide manufacturing restrictions, and more.

Stakeholders responding to recent draft guidance from the US Food and Drug Administration (FDA) on the use of minimal residual disease (MRD) and complete response (CR) primary endpoints for multiple myeloma accelerated approval products say they want more examples of appropriate use of these endpoints, and for the agency to consider expanding the draft guidance to drugs and biologics for other hematologic malignancies.

The US Food and Drug Administration (FDA) and the generic drug industry have reached agreement on some areas amid negotiations to reauthorize the Generic Drug User Fee Amendments (GDUFA IV) program, while other topics, such as drug master files (DMFs) and forfeiture determinations are still being discussed.

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

The European Medicines Agency has finalized its reflection paper on a tailored clinical approach to biosimilar development, revising the wording on when it may waive the need for comparative efficacy studies.