Podcast: Unpacking FDA's Final Clinical Decision Support Guidance - Diagnosing Health Care
Wiley Webinar: Biotech Briefings – Interim Update on Regulatory Developments Relevant to Plant Biostimulants
Edible Bites Episode 2: Cannabis and Life Sciences Video Webinar Series
On January 6, 2025, FDA published a final version of its guidance document, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products.” This...more
On January 6, 2025, the FDA released final guidance for industry entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions...more
The final guidance describes FDA’s enforcement discretion policy for sharing scientific information on unapproved uses of approved products and suggests a safe harbor for sharing off-label information consistent with the...more
The Food and Drug Administration (FDA) recently issued a Notice announcing the availability of an updated final guidance for the industry entitled “Registration and Listing of Cosmetic Product Facilities and Products.” The...more
The Chips and Science Act of 2022 (CHIPS Act) added Section 48D to the Internal Revenue Code (Code) to incentivize the manufacture of semiconductors and semiconductor manufacturing equipment in the U.S. The credit is equal to...more
The Federal Register on May 6, 2024, published final regulations issued by the U.S. Department of the Treasury and IRS under the clean vehicle tax credits found at Sections 25E (previously owned clean vehicles) and 30D (clean...more
On December 26, 2023, the Food and Drug Administration (FDA) issued a Small Entity Compliance Guide Final Guidance Document: Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear,...more
On April 15, the Equal Employment Opportunity Commission (EEOC) issued its long-awaited final rule and interpretive guidance implementing the Pregnant Workers Fairness Act (PWFA). As noted in AFS’s previous alerts (here...more
Senators Focus Attention on Litigation Funding’s Opacity - Building on the momentum we previously noted related to litigation funding, on September 14, Senator John Kennedy introduced the Protecting Our Courts from Foreign...more
On April 6, 2023, the New York City Department of Consumer and Worker Protection (“DCWP”) issued a Final Rule to provide guidance regarding the City’s Automated Employment Decision Tool (“AEDT”) Law, which we covered in more...more
Key Point - The FCA is introducing a new Principle for Businesses, namely Principle 12: “A firm must act to deliver good outcomes for retail customers.” Firms will need to assess and evidence how they are acting to...more
On September 24, 2020, FDA announced that it was taking action to help lower prescription drug prices by issuing a final rule and a final guidance aimed at facilitating the safe importation of certain prescription drugs....more
On September 24, 2020 the U.S. Food and Drug Administration took two major steps to implement its Safe Importation Action Plan, including publishing a new Final Rule allowing the importation of certain prescription drugs from...more
On May 30, 2019, the U.S. Environmental Protection Agency (EPA) issued a final memorandum on fine particulate matter (PM2.5) precursor demonstration guidance. Memorandum from Scott Mathias, Acting Director, EPA Air Quality...more
Federal Court finds invalidity allegations relating to patent for metformin formulations not justified - On March 8, 2019, Justice Fothergill granted Valeant Canada’s application for an order prohibiting the Minister of...more
On August 25, 2016, the Federal Acquisition Regulatory Council issued final rules and the Department of Labor (DOL) published final guidance implementing President Obama’s 2014 “Fair Pay and Safe Workplaces” Executive Order...more
On May 8, 2014, the Internal Revenue Service published final Treasury Regulations, §1.67-4, prescribing when costs incurred by estates or nongrantor trusts are subject to the 2-percent floor for miscellaneous itemized...more