Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 243: HIPAA Compliance and Potential Changes with Shannon Lipham of Maynard Nexsen
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 242: Business Planning in Healthcare & Life Sciences with Jennifer McEwen of Maynard Nexsen
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 241: Fighting Nurse Burnout with Data-Driven Innovation with Dr. Ecoee Rooney of Indicator Sciences
Unexpected Paths to IP Law with Dan Young and Colin White
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 237: Tackling Cancer with Cellular Immunotherapy with Dr. Leonardo Ferreira of Torpedo Bio
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 236: Advocating for Accessible Diagnoses with Sydney Severance of Operation Upright
Taking the Pulse: A Health Care and Life Sciences Video Podcast | Episode 235: Revolutionizing Cancer Care with Eric Perrault of Kiyatec
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 234: Life-Saving Collaboration in the Life Sciences Industry with John Crowley, President & CEO of BIO
AGG Talks: Cross-Border Business Podcast - Episode 28: How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 233: Prioritizing Women’s Health Through Innovation with Lindsey Calcutt of Incora Health
Taking the Pulse: A Health Care and Life Sciences Video Podcast | Episode 232: Commercial Real Estate for Life Sciences Companies with Vinnie Durand of Savills
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 231: Advancing the Life Sciences Industry with Kendalle O’Connell of MassBio
Episode 230: Innovations in Cancer Treatment with Dr. Ray DuBois of MUSC Hollings Center
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 229: Public Health in South Carolina with Dr. Edward Simmer of SC Dept of Public Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 228: Designing & Manufacturing Auto-Injectors with Kimberlee Steele of SHL Medical
AGG Talks: Cross-Border Business Podcast - Episode 27: U.S. Healthcare Reimbursement Guidance for Foreign Life Sciences Companies
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 227: What’s Next for America’s Life Sciences Industry with Arda Ural of EY
Taking the Pulse, A Health Care and Life Sciences Video Podcast | SCbio 2025 Preview with President & CEO James Chappell
Novo Nordisk recently made headlines petitioning FDA to stop the compounding of its blockbuster GLP-1 products so it can sell its patented semaglutide drugs exclusively. Compounding is the practice of creating new drug...more
On December 28, 2024, Health Canada published proposed amendments to the Food and Drug Regulations and Medical Devices Regulations to address therapeutic product shortages (see our previous article regarding Health Canada’s...more
On December 28, 2024, Health Canada published a regulatory proposal in the Canada Gazette, Part I, Volume 158, Number 52, introducing amendments to the Food and Drug Regulations, CRC, c 870 and the Medical Devices...more
On January 15, 2025, the US Drug Enforcement Administration (DEA) released a proposed rule entitled Special Registrations for Telemedicine and Limited State Telemedicine Registrations. This proposed rule would establish three...more
In August, the U.S. Food and Drug Administration (FDA) issued a new proposed rule that would require importers of electronic nicotine delivery system (ENDS) products to provide an FDA-issued submission tracking number (STN)...more
Welcome to the latest edition of Fenwick’s Securities Law Update. This issue contains news on...more
Over the last several weeks, the Biden administration has released numerous final regulations in order to “beat the clock” before it ticks down to the Congressional Review Act (CRA) deadline. The CRA authorizes Congress to...more
On March 20, 2024, the US Food & Drug Administration (FDA) issued a proposed rule titled Drug Products or Categories of Drug Products that Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the...more
In this issue of our newsletter on developments impacting the life sciences industry, we examine topics including how the increased DOJ and FDA focus on cybersecurity issues could lead to new theories of False Claims Act...more
The highly anticipated rule, which would make explicit that LDTs are medical devices subject to FDA oversight, proposes to end the agency's general enforcement discretion approach to such devices....more
Earlier this month, the Food and Drug Administration (“FDA” or “the Agency”) issued a highly anticipated proposed rule outlining the regulatory framework and implementation plan for Laboratory Developed Tests (“LDTs”). The...more
On September 29, 2023, the Food and Drug Administration (FDA) issued a proposed rule that would end its long-standing policy of enforcement discretion with respect to regulation of laboratory-developed tests (LDTs) (the...more
Of particular interest to clinical laboratories and medical device manufacturers, the U.S. Food and Drug Administration (FDA or the Agency) released a controversial proposed rule on September 29 that would dramatically alter...more
Recent months have seen a heightened interest in artificial intelligence (“AI”)-based technology solutions. Although AI is derived from neural networks that date back to the 1940s, new technologies such as generative AI...more
On June 10, 2022, the Mississippi Board of Pharmacy filed their much-anticipated proposed rule on pharmacy shared services, starting the clock on the 25-day public comment period. The Board simultaneously filed its...more
In the words of the rock band REO Speedwagon, from the 1978 song “Roll with the Changes,” “It had to happen, felt the tables turnin’.” Earlier this month, the Food and Drug Administration’s Device Good Manufacturing Practice...more
On February 23, 2022, the U.S. Food and Drug Administration (FDA) issued a proposed rule seeking to amend the medical device current good manufacturing practice requirements of the Quality System Regulation (QSR). Currently,...more
The FDA recently published a proposed rule to create national licensing standards for Wholesale Drug Distributors and Third-Party Logistic Providers....more
Device and drug manufacturers got a small surprise in the annual Physician Fee Schedule proposed rule (at 40,713-16) issued late in July by the Centers for Medicare & Medicaid Services (CMS) – among many other things, the...more
In a welcome move, on 1 April 2019 the U.S. Food and Drug Administration (FDA) proposed reducing regulatory requirements for a number of radiation-emitting electronic products, including radiation-emitting medical devices. ...more
Yesterday, FDA released a series of guidances that aim to advance the agency’s biosimilars policy framework, along with a proposed rule on the definition of a “biological product,” which incorporates changes made by the...more