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
This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape. FDA rolls out Phase II of long-term sodium reduction plan. FDA has released new,...more
The U.S. Food and Drug Administration (FDA) has recently identified several brands of eye drops that were sold with contaminants. These contaminants—which were introduced into the affected eye drops during the manufacturing...more
Contaminated eye drops present serious risks. Not only can they cause blindness and other serious medical conditions, but they have also been linked to at least four cases of premature death caused by severe bacterial...more
Independent laboratory Valisure filed a March 5, 2024, citizen petition (CP) asserting, based on its own testing, that a number of benzoyl peroxide products contain high levels of benzene and that benzene concentrations are...more
Several companies have recently recalled eye drops due to contamination. However, the risk of contamination is not new, and scientific studies have identified several types of contaminants commonly found in eye drops over the...more
Several companies have recently issued recalls for contaminated eye drops. These eye drops can present severe risks—including the risk of total vision loss due to infections—so it is important to know if your eye drops have...more
On May 10, the U.S. Food and Drug Administration (“FDA”) released a new guidance document Guidance for Industry: Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution,...more
On January 20, 2023, the US Food and Drug Administration’s (FDA) final rule on food traceability will take effect. Regulated entities will have a three-year compliance period, with a current compliance date of January 20,...more
IV hydration clinics engage in sterile compounding activities (combining or mixing ingredients to create a custom drug/medicine for an individual patient), such as creating IV vitamin therapies, etc. This act of drug...more
On May 26, 2022, the U.S. Food and Drug Administration (FDA) issued Warning Letters to four companies concerning the illegal sale of unapproved animal drugs containing cannabidiol (CBD) intended for use in food-producing...more
Earlier this week, the Biden Administration announced a monumental plan to address impacts stemming from per- and polyfluoroalkyl compounds (PFAS). While the announcement details the ongoing and future efforts of eight...more
A coalition of environmental, food safety, and consumer health advocacy groups petitioned the U.S. Food and Drug Administration (FDA) yesterday to ban per- and poly-fluoroalkyl substances (PFAS) from food contact uses, and to...more
On December 11, 2020, a SARS-CoV-2 (COVID-19) vaccine developed by Pfizer and BioNTech became the first to receive Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Since then, two others...more
On July 2, 2020, MasterPharm, LLC, a compounding pharmacy based in South Richmond Hill, New York, announced the recall of various lots of numerous drugs compounded and distributed by the pharmacy. The recall includes...more
FDA issued new guidance on June 19, 2020, advising manufacturers of drugs, biologics, and active pharmaceutical ingredients (APIs) on manufacturing controls to prevent contamination of drugs with SARS-CoV-2, including...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
LEGISLATION, REGULATIONS & STANDARDS - FDA Study Finds Sunscreen is Absorbed into Bloodstream - JAMA has published a study conducted by researchers at the U.S. Food and Drug Administration (FDA) Center for Drug...more
Cannabis / Marijuana- FTC and FDA Issue Warning Letters to Companies Advertising and Selling Cannabidiol Products- The Federal Trade Commission (“FTC”) and the Food & Drug Administration (“FDA”) issued warning letters to...more
Consumer Financial Protection Bureau- 25 Democratic Attorneys General Oppose CFPB Proposed Rule to Delay Compliance Date of Payday Lending Rule- 25 Democratic AGs, led by North Carolina AG Josh Stein, submitted a...more
Welcome to the third issue of Product Lines – our quarterly e-newsletter that focuses on toxic torts and products liability issues. For this edition, we are reporting on several important and timely legal issues. As you...more
For the 26.9 million sufferers of sinus pain and pressure, nasal sprays are one of the most recommended and effective methods of relief. But one product, labeled as a CVS brand nasal mist, is being pulled off the shelves....more
GMA Conference Panels Explore Trends in Class Actions, Organic Production - Litigation, increasing online grocery shopping and consumer concerns regarding product ingredients were hot topics at the 2018 Grocery...more
TSCA/FIFRA/IRIS/NTP/TRI - EPA Releases TRI Preliminary Dataset For Calendar Year 2015: On July 20, 2016, the U.S. Environmental Protection Agency (EPA) announced the availability of the Toxics Release Inventory (TRI)...more
Earlier this year, both patients and providers were shocked when a rash of hospital patients got seriously ill or died after medical devices used to examine their gastrointestinal tracts infected them because they were not...more
This Week: Bipartisan Senate Letter Questions HHS and CMS on Details of State ACA Waivers...OMB Is Reviewing Final Medicaid-Covered Outpatient Drug Rule...Delaware Forgoes Transition to State-Based Exchange....more