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
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
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
As companies prepare upcoming periodic reports, they should focus on carefully reviewing and updating their risk factors. Some of the considerations may include...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
Obtain the guidance you need to master the difficult area of FDA regulatory law - For over 15 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of...more
Enhancing transparency has been one of the FDA’s top priorities for nearly a decade. In late 2016, the agency continued to advance this goal by publishing data relating to food, cosmetics and dietary supplements from its...more
Southern Baptist Hospital of Florida (Hospital) was sued in a medical malpractice action in which the plaintiff sought to discover records relating to "adverse medical incidents" that occurred at the Hospital and involved any...more
Years of adverse-event reports documenting problems associated with compromised food, dangerous drugs and harmful cosmetics are now available to the public. The information can be obtained, free of charge, via a downloadable...more
Based on recent FDA statements, it looks as though the FDA would like to integrate hospital medical device reporting obligations into the National Evaluation System for health Technology (NEST) framework. The NEST system is a...more
Recently, we moderated a panel at the Food and Drug Law Institute’s Annual Conference, where a senior Food and Drug Administration official participated. The individual from the Center for Drug Evaluation and Research made an...more
The U.S. Food and Drug Administration’s requirement that pharmaceutical companies report dangerous side effects cause by medicines they manufacture is being flouted by a few bad actors. Such violations of the federal law are...more
On June 2, 2014, the Food and Drug Administration launched openFDA, a program designed to improve access to publicly available data beginning with adverse event reports. While greater accessibility to adverse event reports...more