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
The FDA recently approved LimaCorporate’s fully 3D-printed glenoid baseplate and humeral stem for use in reverse shoulder replacement....more
In this episode, Rebecca Schaefer and Michael Hinckle review some types of hospital and health system activities that could trigger FDA regulatory oversight. They discuss the FDA’s jurisdiction over IRB’s in medical device...more
Medical device companies have for many years used 3D printing to create innovative products such as custom patient-matched devices and individualized anatomical models for surgical planning. Typically, these activities have...more
The U.S. Food & Drug Administration (FDA) recently issued a discussion paper to gather feedback that will inform future policies and guidance regarding 3D printing medical devices at the point of care. Amidst COVID-19...more
Bye-Bye, Bitcoin: It's Time to Ban Cryptocurrencies - "International banking officials say cryptocurrencies such as bitcoin are speculative assets, not sustainable, usable money." Why this is important: This opinion piece...more
Is 3D printing the next litigation frontier? Litigation over 3D printing will become increasingly more prevalent as the technology becomes less expensive to build due to rising demand, some lawyers say. A federal court in...more
Brexit Effects on Trademarks Beginning January 1 - Trademark owners with registrations in EU where the UK is designated should soon receive notification for treatment of registrations and applications following the Brexit...more
This Diagnosing Health Care episode dives into the key business operations and legal considerations for reshoring active pharmaceutical ingredient (or “API”) and finished drug product manufacturing to the United States. The...more
3-D biomeat: Is it finger-lickin’ good? Biomeat, a.k.a., cultured or cell-based meat, is an emerging area of food science that food manufacturers, food retailers, and restaurant chains are currently monitoring as consumers...more
An unprecedented demand for critical medical products in recent weeks has triggered an urgent interest in the potential of 3D printing to create personal protective equipment (PPE) and other medical devices during the...more
The medical device industry and the Food and Drug Administration (FDA) have been experimenting with three-dimensional (3D) printing for years. Shortages of medical devices such as personal protective equipment (PPE) and...more
On March 26, 2020, the U.S. Food and Drug Administration (FDA) issued guidance surrounding the use of 3D printing on medical devices, accessories, components, and parts during the COVID-19 pandemic....more
Starting in February 2020, the US Food and Drug Administration (the “FDA”) began using its Emergency Use Authorization (“EUA”) powers under Section 564 of the Federal Food, Drug, and Cosmetic Act (“FD&C”) to allow unapproved...more
On March 26, 2020, the US Food and Drug Administration issued FAQs on 3D printing of medical devices, accessories, components and parts during the Coronavirus (COVID-19) pandemic. While the use of 3D printers can help address...more
We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more
Since its advent more than 30 years ago, the 3D printing market has grown, and will continue to expand for a myriad of reasons, including sustainability and reduced energy consumption. As the process, including the applicable...more
FSMA, Prop. 65 and Supply Chain Issues Among Subjects of Food Law Conferenc - In-house and outside counsel joined representatives from the U.S. Food and Drug Administration (FDA), Department of Agriculture (USDA) 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
In recent years, market interest in meat substitutes has aligned with advances in cell culture techniques to support the emergence of lab-grown meat or ”cultured meat” as an alternative to farm-grown meat products. A product...more
The U.S. Food and Drug Administration (FDA) recently finalized its publication on additive manufacturing (commonly referred to as 3-D printing) for medical devices. According to FDA Commissioner Scott Gottlieb, the guidance...more
In December, the U.S. Food and Drug Administration (FDA) issued guidance on Technical Considerations for Additive Manufactured Medical Devices. The guidance represents FDA’s efforts to provide regulatory direction about...more
On December 5, 2017, the U.S. Food and Drug Administration (FDA or the Agency) finalized its “leapfrog guidance” entitled, “Technical Considerations for Additive Manufactured Devices”. ...more
The U.S. Food and Drug Administration released finalized guidance regarding 3D printing in medical devices. The guidance document, which issued on December 5, 2017, is based on the FDA’s review of more than 100 devices...more
Massachusetts Federal Court Dismisses Putative Class Action Because Defendant’s Unconditional Checks for Named Plaintiff’s Maximum Damages, Even Though Uncashed, Mooted Suit - In Demmler v. ACH Food Companies, Civil No....more
David Ferrera, partner in Nutter’s Litigation Department and chair of the firm’s Product Liability and Toxic Tort Litigation practice group, and Robyn Maguire, partner in Nutter’s Litigation Department and a member of the...more