The US Food and Drug Administration (FDA) published a draft guidance outlining how sponsors of artificial intelligence and machine learning (AI/ML) products can submit predetermined change control plans (PCCP) in their product applications. It has been a priority for industry, which successfully lobbied for the issue as part of last year’s omnibus spending bill.   The draft guidance outlines what the agency needs from AI/ML device sponsors to ensure their change cont...

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 Robert Califf testified before the House Appropriations committee on the agency’s FY 2024 budget request. FDA also issued guidance on implementing ISO IDMP and approved the first over-the-counter naloxone product to treat opioid overdoses.   On Wednesday, ...

US House lawmakers have re-introduced a bill that would give the Food and Drug Administration (FDA) explicit authority to regulate certain laboratory-developed tests (LDT). The agency has long sought to regulate such tests that are currently overseen by the Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA).   Reps. Larry Bucshon, R-IN, and Diana DeGette, D-CO, reintroduced the Verifying Accurate, Leading-edge ...

The European Commission has answered questions on “practical aspects” related to legislation to extend the transition period for the Medical Device Regulation (MDR). In the question-and-answer document, the Commission clarifies the scope of the extension and how companies can benefit from the changes.   Across the 10-page text, the Commission answers 18 questions about the applicability of the revised transitional period to custom-made devices, how to show a legacy dev...

BASEL, Switzerland – The European Medicines Agency’s (EMA) newly formed Quality Innovation Group (QIG) aims to clarify regulatory expectations for innovative manufacturing technologies to help bring these products to market, and is looking in the areas of decentralized manufacturing, 3D technology, and continuous manufacturing, asserted Veronika Jekerle, EMA head of pharmaceutical quality at DIA Europe 2023.   At the meeting, Jekerle described the mandate of QIG, which...

In Focus: US US FDA approves over-the-counter sale of overdose reversal drug Narcan ( Reuters ) ( Pink Sheet ) ( Endpoints ) Otsuka, Lundbeck eye Alzheimer's indication in FDA adcomm for Rexulti label expansion ( Endpoints ) Batch Testing Of All Imported Drugs Floated At House Appropriations Hearing ( The Pink Sheet ) FDA lifts partial hold on Blueprint's CDK2 inhibitor ( Endpoints ) HHS Streamlines Kids Research Review Process Across Department ( Bloomberg ) Short...

BASEL, Switzerland – Remote or virtual inspections are now permanent fixtures in the toolboxes of the World Health Organization (WHO) and the European Directorate for the Quality of Medicines (EDQM) as they assess the pharmaceutical industry’s compliance with good manufacturing practices (GMPs). While this inspection method was once viewed as a temporary tool to counteract travel restrictions wrought by the pandemic, they are now viewed as a routine method of inspecting. ...

While final guidance gives the US Food and Drug Administration (FDA) the authority to deny a new product application  the product’s cybersecurity measures don’t pass muster, regulators say they will wait until October before they will exert that authority.   On 29 March, FDA published a much-anticipated cybersecurity final guidance that allows it to issue refuse to accept (RTA) decisions to medical device sponsors if the agency is concerned their product doesn’t meet i...

The US Food and Drug Administration (FDA) has released a new draft guidance outlining what information should be included in premarket submissions for orthopedic non-spinal bone plates, screws, and washers.   The draft guidance is intended to clarify information in 510(k) submissions for class II orthopedic non-spinal, non-resorbable medical devices, including bone plates, screw systems, standalone bone screws, and washers for bone fixation. The agency’s goal with the ...

Olga van Grol-Lawlor didn’t know what regulatory affairs was when she interviewed for her first job in the profession.  “They asked me if I knew what regulatory affairs was. The truthful answer was no, but they grilled me anyway for about 45 minutes.”  She got the job, started working in regulatory affairs and never looked back.  Now she’s a manager of global regulatory intelligence and advocacy at Boston Scientific, where she’s worked since 2016. She’s based in the Ne...

The US Food and Drug Administration has finalized a guidance that allows some manufacturers to submit 510(k) applications for soft contact lenses based on their performance criteria rather than by comparison to a predicate device.   “FDA recognizes that in some cases, it may be more burdensome for a submitter to conduct testing against an appropriate predicate device to demonstrate equivalence for the necessary set of performance and technological characteristics than ...

The US Food and Drug Administration (FDA) asserts that it is on track to release a final rule this December that harmonizes the agency’s decades-old Quality System Regulation (QSR) with international standard ISO 13485:2016. Despite that deadline being roughly eight months away, it’s never too early for industry to prep for its arrival, two longtime experts say.   The FDA released its draft Quality Management System Regulation (QMSR) in February 2022; the agency had ...