Medical Device Legal News with Sam Bernstein: Episode 11
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 The draft guidance...more
On July 8, 2024, the Food and Drug Administration (FDA) released updated draft guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers,” that replaces similar guidance from...more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The U.S. Food and Drug Administration (FDA) recently released a draft guidance describing its proposed approach to reviewing and authorizing a predetermined change control plan (PCCP) in a marketing submission for a device...more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We recently posted on a new FDA draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers,” aimed at providing “answers to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On August 20, 2024, the Federal Trade Commission (FTC) submitted a comment supporting the FDA’s June 2024 draft guidance “Considerations for Demonstrating Interchangeability with a Reference Product: Update” that revises the...more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On August 22, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled, Predetermined Change Control Plans for Medical Devices. The draft guidance describes how FDA plans to implement new...more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information in China has always been different to other jurisdictions, with a focus on risk of harm at its heart, new draft guidance should make it easier for organisations to map...more
On August 9, Maryland’s Prescription Drug Affordability Board (PDAB) released its draft action plan for establishing upper payment limits (UPLs) for drugs identified as causing or likely to cause affordability challenges. The...more
The European Commission has published for public consultation its long-awaited draft Guidelines on exclusionary abuses (draft Guidelines). The draft Guidelines aim at making it faster and easier for the Commission to pursue...more
On August 15, 2024, the U.S. Food and Drug Administration (FDA) issued draft guidance with new, voluntary sodium reduction targets for foods, with the goal of reducing sodium intake to 2,750 milligrams (mg) per day from the...more
LEGISLATION, REGULATIONS & STANDARDS - FDA Announces Draft Guidance for Sodium Reduction Efforts - The U.S. Food and Drug Administration (FDA) has issued draft guidance that would support reducing the average...more
The Department of Commerce released three final guidance documents incorporating public comments from earlier this spring which provide recommendations for managing AI risk, securing AI software development processes, and...more
On July 26, the U.S. Department of Commerce announced new guidance and tools to enhance the safety, security, and trustworthiness of AI systems pursuant to President Biden’s Executive Order on AI (covered by InfoBytes here)....more
Many life sciences stakeholders are familiar with “traditional” designation programs operated by the Food and Drug Administration (FDA) in exercising its medical product authorities, such as the orphan drug designation and...more
As discussed in a prior Goodwin Alert, the US Food and Drug Administration (FDA) recently released Draft Guidance for designating a platform technology for drug development pursuant to § 560k of the Federal Food, Drug, and...more
On July 25, 2024, the US Food and Drug Administration (FDA) announced the release of a final version of its Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making...more
The Draft Guidelines set out the European Commission (EC)’s approach on exclusionary abuse by dominant undertakings. The EC is proposing a shift away from the effects-based approach set out in its earlier enforcement...more
As announced earlier this month, the longstanding Memorandum of Understanding (MOU) between the Food and Drug Administration (FDA or Agency) and the Association of American Feed Controls Officials (AAFCO) will expire on...more
The U.S. Food and Drug Administration (FDA) recently released draft guidance on how and when medical device manufacturers and pharmaceutical companies can respond to misinformation about their products online. While not yet...more
On July 23, 2024, the FDA issued a draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers.”...more
The United States Environmental Protection Agency (“EPA”) released on July 25th a document titled: Draft Insecticide Strategy to Reduce Exposure of Federally Listed Endangered and Threatened Species and Designated...more
Misinformation shared by independent third parties presents a significant public health concern because it can lead patients and healthcare providers to forgo treatments that are safe and effective or choose treatments that...more