Medical Device Legal News with Sam Bernstein: Episode 11
On December 5, 2024, FDA unveiled the draft guidance for industry regarding accelerated approval for drugs and biologics. This guidance provides additional information regarding the development of drugs and biologics to treat...more
On November 20, 2024, the U.S. Environmental Protection Agency (EPA) announced the release of its draft guidance for public comment to support registration and evaluation of efficacy claims for pre-saturated antimicrobial...more
On November 21, 2024, the U.S. EPA released a new draft framework – the Interim Framework for Advancing Consideration of Cumulative Impacts – intended to provide EPA’s employees with guidance for how they should consider...more
The draft guidelines provide further clarification to the EDPB’s interpretation of legitimate interests, and suggest a potential divergence with the UK ICO....more
On this episode of Ropes & Gray’s podcast series Non-binding Guidance, health care partner David Peloquin and life sciences regulatory and compliance counsel Sarah Blankstein discuss the FDA's recent draft guidance on...more
We are pleased to share our Q3 Food & Consumer Packaged Goods (CPG) Legal Trends report. This report is a bite-size version of our annual year in review, providing timely insights on legal trends in the space. In Q4 of...more
The draft U.K. Greenhouse Gas Emissions Trading Scheme (Amendment) (No. 2) Order 2024 have been published, together with an explanatory memorandum. The Order makes changes to the U.K. Emissions Trading Scheme, including the...more
On Sept. 18, 2024, the U.S. Food & Drug Administration (FDA) issued a final guidance document titled “Conducting Clinical Trials With Decentralized Elements, Guidance for Industry, Investigators, and Other Interested...more
On 9 October 2024, the European Data Protection Board (EDPB) published its draft Guidelines on the processing of personal data based on legitimate interest for public consultation. The draft Guidelines, adopted on 8 October...more
Novo Nordisk May Proceed with Its Ozempic Suit Against DCA Pharmacy. A Tennessee federal court denied DCA Pharmacy’s motion to dismiss a lawsuit filed by Novo Nordisk Inc. alleging a violation of Tennessee state unfair and...more
The U.S. Food and Drug Administration (FDA) finalized its revised guidance summarizing how it intends regulate the use of electronic systems, records, and signatures in clinical investigations to account for advances in...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape....more
The U.K. Payment Systems Regulator has published a policy statement and draft guidance to support payment service providers in assessing whether an authorized push payment scam claim raised by a consumer is not reimbursable...more
This newsletter is a summary of the antitrust developments we think are most interesting to your business. James Webber (partner based in London) and Jess Bowring (counsel based in London) are our editors this month. They...more
The Israel Securities Authority recently published a draft of a new directive for payment companies and holders of basic initiation licenses or approvals regarding reporting to the Authority. According to the Draft, payment...more
On August 21, the National Institute of Standards and Technology (NIST) released the second draft of its revised Digital Identity Guidance, which NIST first published in 2004 and last revised in 2017. The draft guidance...more
On July 8, 2024, the Food and Drug Administration (FDA) released updated draft guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers,” that replaces similar guidance from...more
The European Commission (EC) has published draft antitrust guidelines on exclusionary abuses (the Draft Guidelines) and is conducting a public consultation to gather feedback....more
The U.S. Food and Drug Administration (FDA) recently released a draft guidance describing its proposed approach to reviewing and authorizing a predetermined change control plan (PCCP) in a marketing submission for a device...more
On August 21, Oregon’s Prescription Drug Affordability Board (PDAB) reviewed a draft upper payment limit (UPL) constituent engagement report, which captured feedback from patients, providers, health plans, manufacturers, and...more
We recently posted on a new FDA draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers,” aimed at providing “answers to commonly asked questions...more
On August 20, 2024, the Federal Trade Commission (FTC) submitted a comment supporting the FDA’s June 2024 draft guidance “Considerations for Demonstrating Interchangeability with a Reference Product: Update” that revises the...more
The U.S. Food and Drug Administration (FDA) has issued a Safety Communication advising healthcare providers to stop implanting Equinoxe Shoulder System joint replacement devices manufactured by Exactech. The Safety...more
On August 22, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled, Predetermined Change Control Plans for Medical Devices. The draft guidance describes how FDA plans to implement new...more
While the definition of sensitive personal information in China has always been different to other jurisdictions, with a focus on risk of harm at its heart, new draft guidance should make it easier for organisations to map...more