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
Our Food & Beverage and FDA teams explore a plan from a trio of federal agencies that seeks to implement regulatory reform and update the Coordinated Framework for the Regulation of Biotechnology....more
A popular New Year’s trend is to say “goodbye” to all the things that didn’t serve you in 2023, as you usher in new intentions and habits for 2024. Although there were many great trial outcomes and continuing scientific wins...more
With COVID diagnoses spiking across the United States this summer, we cannot yet claim that the pandemic is behind us. In fact, we are still experiencing residual medical device and equipment shortages, which has caused...more
Report on Research Compliance 18, no. 6 (June 2021) - Clemson University is pushing back against recommendations by auditors for the National Science Foundation Office of Inspector General (OIG) that it repay $276,440,...more
On Thursday, August 6, 2020 President Trump signed an Executive Order, mandating that certain drugs and medical supplies purchased by federal agencies, including the Department of Health and Human Services, Department of...more
Amidst a flurry of policymaking from the White House last week, President Trump issued the Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States on August...more
On August 6, 2020, U.S. President Donald Trump issued his much-anticipated "Buy American" Executive Order (EO), intended to increase and support domestic manufacture and Federal government procurement of "essential...more
Litigation Update - On January 30, 2020, class action, consumer protection and pharmaceutical lawyers from around the country will be in federal court in Tampa, Florida to argue before a panel of federal judges whether...more
The U.S. Food and Drug Administration (FDA), on September 30, 2019, announced the availability of a draft guidance for industry (GFI) #171 titled “Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and...more
Consumer Financial Protection Bureau- CFPB Changes Policies Regarding Civil Investigative Demands- The Consumer Financial Protection Bureau (“CFPB”) announced changes to its policies regarding civil investigative demands...more
• The U.S. Environmental Protection Agency (EPA) has published a new rule to address the handling, storage, transportation and disposal of hazardous waste pharmaceuticals by healthcare facilities and reverse distributors. •...more
While much of the environmental bar was focused on the Waters of the U.S. rulemaking, on December 11, U.S. EPA Acting Administrator Andrew Wheeler signed the new hazardous waste pharmaceutical rule. The final rule retains a...more
Following a truncated August recess, the House and the Senate returned to Washington after Labor Day with a full plate of legislative items to address prior to the end of the fiscal year on September 30. That list includes...more
On January 20, 2017, businessman Donald J. Trump was sworn in as the 45th President of the United States following a contentious and unconventional 2016 presidential election. Republicans also successfully maintained control...more
The second day began with a deep dive into the development of advanced biological drugs for animal use. David Brake, Ph.D., Founder and Principal, BioQuest Associates, LLC, helped explain the split between USDA and FDA...more
On September 10-11, the American Conference Institute (ACI) held its inaugural Animal Health and Veterinary Drugs and Therapeutics Conference in New York City. The Conference featured two workshops: a pre-conference overview...more
EPA Releases TSCA Assessment Documents For Flame Retardant Chemicals: On August 18, 2014, the U.S. Environmental Protection Agency (EPA) released for public comment three Problem Formulation and Initial Assessment documents...more
In 2008, the U.S. Environmental Protection Agency (EPA) seemed to be on the road to providing some much-needed clarity to hospitals and other medical facilities concerning the disposal of pharmaceuticals by proposing that...more