I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Quality Agreements for FDA-Regulated Products: Looking Under the Hood
Podcast: Non-binding Guidance: SEC Disclosure Issues for Life Sciences Companies
The recent extreme weather events in the UAE, characterised by unprecedented rain and flooding, serve as a stark reminder of the broader implications such severe weather can have on construction projects. We explore these...more
Combination products present a tremendous opportunity to improve health outcomes, because they leverage multiple disciplines. If we were, for example, to focus on drugs alone with little thought to how they might be...more
Thanks to the Food and Drug Omnibus Reform Act (FDORA), cosmetic companies will soon be subject to new requirements for registration, product listing, disclosure of ingredients, adverse event reporting, safety substantiation,...more
The U.S. Department of Health and Human Service’s Office of Inspector General published two Adverse Events Toolkits on July 6 to assist health care providers, government agencies and researchers identify and measure adverse...more
In prior posts here and here, I analyzed new data obtained from FDA through the Freedom of Information Act about FOIA requests. I looked at response times and then started to dive into the topics that requesters were asking...more
Massachusetts federal and state courts issued several important product liability decisions in 2022. Nutter’s Product Liability practice group reviewed these cases and report on their significant holdings as follows ...more
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was passed by the U.S. Congress as part of the omnibus Consolidated Appropriations Act enacted on December 29, 2022 and will grant the U.S. Food and Drug...more
In June of this year, FDA announced a proposed rule that would permit approval for nonprescription drug products with an Additional Condition for Nonprescription Use—a category of nonprescription drugs where FDA determines...more
Through nearly 19 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Don’t miss your opportunity to join their ranks....more
Aside from a small number of companies the FDA has permitted to pursue the development of psilocybin therapies (e.g., Compass), the majority of psychedelic mushroom sales in the U.S. currently violate both state and federal...more
What You Need to Know About Kidney Damage and Bone Loss Claims - For individuals who either live with or are at risk of contracting HIV, a medication that provides both (partial) treatment of HIV symptoms and pre-exposure...more
The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention issued warnings to the public regarding the potential health risks of using Delta-8 THC products on September 14, 2021...more
As companies prepare upcoming periodic reports, they should focus on carefully reviewing and updating their risk factors. Some of the considerations may include...more
The Illinois Supreme Court recently agreed to hear an appeal of an Appellate Court’s decision addressing whether an employee’s claim for damages under Illinois’s Biometric Information Protection Act is preempted by the...more
ACI’s FDA Boot Camp returns in a completely interactive virtual format to help life sciences attorneys and executives to master the fundamentals of FDA Regulation... Gain essential working knowledge of core FDA concepts,...more
Earlier this year, the California Court of Appeals in Mize v. Mentor Worldwide LLC, 51 Cal.App.5th 850 (2020), reversed a trial court’s dismissal of failure to warn and other claims against a medical device manufacturer,...more
In this week’s episode, Kenneth Kennedy discusses FDA’s ongoing focus on the issuance of warning letters to firms marketing fraudulent COVID-19 products, and to manufacturers who have failed to meet certain requirements under...more
AGG is proud to introduce our newest podcast series titled “I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues.” Each month, we will release a new podcast where different members of our Food and Drug practice...more
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In Tuesday's Report: FDA...more
On September 9, the U.S. Food and Drug Administration (FDA) updated its online FAQs, entitled “Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance...more
As we discussed in our last update on the Food and Drug Administration’s Comprehensive Regenerative Medicine Policy Framework back in December 2019 (during the much simpler, pre-COVID-19 world), this coming November will...more
We’ve been blogging periodically on the various actions taken and enforcement policies being developed by the Food and Drug Administration (FDA) to support and expand the national response to the declared COVID-19 public...more
In light of the coronavirus (COVID-19) outbreak, the US Food and Drug Administration (FDA) recently issued a guidance on adverse event (AE) report for drugs, biologics, medical devices, dietary supplements, and other products...more
West Palm Beach, Florida - The US Food and Drug Administration (FDA), has recently taken the extraordinary step of requiring The Breast Institute at the JFK Medical Center North, located at 2201 45th Street in West Palm...more
FDA has just published a new Guidance that will allow for the suspension of reporting of certain adverse event reports while the COVID-19 pandemic continues. This Guidance takes effect immediately and applies to postmarketing...more