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
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 226: Orlando Health’s Expansions and Research with Amy Allen and Thibaut Van Marke of Orlando Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 225: Cancer Care Access & Treatments with Dr. Sengar of Alabama Cancer Care
Building a Business at the Intersection of Neurodata and Innovation With Rob Cooley
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Wolf Greenfield’s New Shareholders
FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support a regulatory decision about a drug or biological product’s safety, effectiveness, or...more
On May 10, 2024, the United States Patent and Trademark Office (“USPTO”) published a notice of proposed rulemaking in the Federal Register that could dramatically impact prosecution practices, especially for those...more
On December 8, 2023, the National Institute of Standards and Technology (NIST) published a draft guidance document regarding the government’s exercise of “march-in” rights under the Bayh-Dole Act. The Bayh-Dole march-in...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
The U.S. Food and Drug Administration (FDA) recently published a draft of its updated Good Clinical Practice (GCP) guidance for modernizing clinical trials. The draft guidance will be open for public comment for 60 days from...more
The U.S. Food and Drug Administration (“FDA”) has announced its first-ever draft guidance specifically addressing the use of artificial intelligence/machine learning (“AI/ML”) in medical devices (“Draft Guidance”).This...more
The U.S. Food and Drug Administration (FDA) has published updated draft guidance for industry, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations–Questions and Answers (Draft...more
On March 15, 2023, the U.S. Food and Drug Administration (“FDA”) issued updated draft guidance, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations–Questions and Answers (“Draft...more
The response includes a considered implementation plan to strengthen the regulation of medical devices and in vitro diagnostics, improve patient safety, and foster innovation post-Brexit. On 26 June 2022, the UK Medicines...more
On June 29-30, 2022, the U.S. Food and Drug Administration (FDA) will hold a virtual public meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) to discuss its regulatory expectations for...more
Last week the U.S. Food and Drug Administration (FDA) issued a long-awaited draft guidance, Human Gene Therapy Products Incorporating Human Genome Editing, that addresses key considerations for the development of gene therapy...more
On October 27, 2021, the U.S. Food and Drug Administration (FDA), Health Canada and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a set of ten guiding principles meant to aid the...more
On October 27, 2021, pursuant to the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device Action Plan (Action Plan), the US Food and Drug Administration (FDA) released its Good Machine Learning...more
On August 9, the U.S. Food and Drug Administration (FDA) published a notice announcing its implementation of the U.S. Court of Appeals for the D.C. Circuit’s April 2021 decision in Genus Medical Technologies LLC v. U.S. Food...more
On June 24, 2021, the Food and Drug Administration (FDA) issued the long-awaited Remanufacturing of Medical Devices Draft Guidance (Draft Remanufacturing Guidance), which describes the agency’s current thinking on activities...more
Earlier this month, the National Academies Committee on Equitable Allocation of Vaccine for the Novel Coronavirus released its Final Framework to guide US distribution and administration of a COVID-19 vaccine, once available....more
Earlier today, the Committee on Equitable Allocation of Vaccine for the Novel Coronavirus released preliminary guidelines on the allocation of initial and limited supplies of a forthcoming COVID-19 vaccine. Once finalized,...more
Personalized medicine selects the best therapy or course of treatment for each patient based on diagnostic testing. In one aspect, personalized medicine uses pharmacogenetic testing to provide information regarding: 1) how an...more
The Situation: Artificial intelligence ("AI") is emerging as a key driver of innovation in the biopharmaceutical industry, which uses AI in research and development ("R&D") to analyze big data. The Result: AI is already...more
The Food and Drug Administration has issued a new draft breast implant guidance recommending that manufacturers strengthen labeling about the potential complications and risks of the medical devices, particularly by adding...more
On 14 August 2019 the U.S. Department of Commerce published a proposed change to the list of "Schedule 1" chemicals in the "Annex on Chemicals" to the Chemical Weapons Convention (CWC). ...more
On January 7, 2019 the U.S. Food and Drug Administration (“FDA”) issued three new documents related to the Agency’s Software Precertification (“Pre-Cert”) Pilot Program. These documents include (1) the Developing a Software...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
Despite regulations, litigation, and significant draft guidance, the future of regulation of HCT/Ps remains up in the air. Learn what you need to know quickly with these seven questions and answers....more
In view of the U.S. Supreme Court’s decisions in Alice, Myriad, and Mayo, the United States Patent and Trademark Office (USPTO) has issued a series of guidance documents on patent subject matter eligibility under 35 U.S.C. §...more