Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Video: Food for Thought and Thoughts on Food: Innovating USDA Science with Sanah Baig, Deputy Under Secretary for Research, Education, and Economics
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Litigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast
Changes in FDA, Cannabis Policies and AI Developments
Ad Law Tool Kit Show – Episode 2 – Marketing FDA-Regulated Products
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
A Look Into the FDA and USDA Regulatory Regimes
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Dietary Supplements – Navigating the Regulatory Maze – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 164: Emily Chee, US General Manager of Novartis Gene Therapies
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
Medical Device Legal News with Sam Bernstein: Episode 14
Medical Device Legal News with Sam Bernstein: Episode 11
Medical Device Legal News with Sam Bernstein: Episode 10
Medical Device Legal News with Sam Bernstein: Episode 9
Medical Device Legal News with Sam Bernstein: Episode 8
Ten years in the making, and full implementation is finally coming. In about a year—beginning on November 27, 2023—prescription drug manufacturers and their supply chain partners will be required to fully trace and verify...more
In one year (plus a few days, as of this writing), regulation of the U.S. drug supply chain will be historically changed. On November 27, 2023, the final phase of the Drug Supply Chain Security Act (DSCSA) goes into effect....more
FDA recently issued guidance announcing its intent to exercise enforcement discretion for several specific provisions in the agency’s regulations implementing the FDA Food Safety Modernization Act (FSMA). The guidance is...more
The U.S. Food and Drug Administration (FDA) has released the third and final installment of its Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (“IA rule”)....more
On November 6, 2019, the Food and Drug Administration (FDA) announced in a Constituent Update that it will continue to exercise enforcement discretion with respect to certain supply-chain program requirements applicable to...more
In this month's edition of our Privacy & Cybersecurity Update, we examine the California attorney general's draft regulations on the California Consumer Privacy Act, the CJEU's clarified rulings on the use of cookies, the...more
In a signal to industry that the period for education and enforcement discretion related to the Foreign Supplier Verification Programs (FSVP) may be concluding, the Food and Drug Administration (FDA) recently issued its first...more
The U.S. Food and Drug Administration (FDA) recently issued the first Warning Letter addressing violations of the Foreign Supplier Verification Program (FSVP) rule, one of the seven major FDA Food Safety Modernization Act...more
In her report on the 2008 Canadian listeriosis outbreak, Independent Investigator Sheila Weatherill highlighted the need for “substantial consolidation and modernization” of the legislative and regulatory framework governing...more
The Food and Drug Administration (FDA) recently made two notable announcements regarding implementation of the FDA Food Safety Modernization Act (FSMA). First, FDA released a tool to assist companies with meeting supplier...more
On July 20, 2017, FDA published two announcements in the Federal Register related to the development of an electronic, interoperable system to identify and trace certain prescription drugs distributed within the United...more
On April 19, 2017, FDA announced that both the United States and Australia have recognized each other's food safety systems as comparable to each other. This is the third time that the FDA has given this recognition to a...more
Manufacturers must begin to comply with the Drug Supply Chain Security Act (DSCSA) serialization and verification requirements on November 27, 2017 (Compliance Date). Serialization and verification are intended to enable...more
Last week FDA published a notice of public meeting and a request for comments regarding certain aspects of the Drug Supply Chain Security Act (DSCSA). The meeting will take place on October 14, 2016 at the Agency’s campus in...more
Counterfeit and adulterated prescription drugs in the supply distribution chain pose a significant risk to patient safety. On November 27, 2013, President Obama enacted the Drug Supply Chain Security Act (DSCSA), which amends...more
In order to improve drug security throughout the supply chain, and to facilitate drug recalls and to address drug importation, diversion, and counterfeiting, Congress passed the Drug Supply Chain Security Act (the "DSCSA")....more