Life Sciences, Regulatory Oversight, Healthcare

FDA Moves Forward on Fluoropolymers

Akin Gump Strauss Hauer & Feld LLP on 8/7/2025

On August 6, 2025, the U.S. Food and Drug Administration (FDA) became the latest governmental agency to confirm that fluoropolymers are both safe and necessary. After an independent safety review of fluoropolymers in medical...more

The Importance of a Clinical Trial Strategy

Gardner Law on 6/17/2025

Developing a medical product, such as a medical device, comes with important milestones that can cause a project to sink or swim. One major milestone is amassing the clinical data needed to support pre-market submissions....more

FDA Greenlights Commercialization of Gene-Edited Pig Resistant to Devastating Swine Disease PRRSV

ArentFox Schiff on 6/5/2025

On April 30, the US Food and Drug Administration (FDA), approved the use of a gene-edited pig to confer resistance to Porcine Reproductive and Respiratory Syndrome (PRRS), a devastating swine disease....more

Regulatory Escalation in Pharma Sector: China Imposes First Executive Sanctions in a Cartel Case

Dacheng on 5/27/2025

On May 9, 2025, the Tianjin Municipal Administration for Market Regulation (“Tianjin AMR”) announced administrative penalties against four manufacturers of dexamethasone sodium phosphate (“DSP”) active pharmaceutical...more

A Model’s Credibility Is in the Details: FDA Draft Guidance on the Use of AI Models in Drug and Biological Product Development

Troutman Pepper Locke on 2/13/2025

In January, the U.S. Food and Drug Administration (FDA) issued its first guidance on the use of artificial intelligence (AI) models in drug development and in regulatory submissions titled, “Considerations for the Use of...more

9th Circuit Finds That Stromal Vascular Fraction (SVF) Procedures Constitute Treatments As Drugs

IR Global on 1/14/2025

In United States v. California Stem Cell Treatment Center, Inc.[1], the FDA brought a lawsuit against doctors who create and administer a stem cell mixture called stromal vascular fraction (SVF), alleging violations of the...more

FDA Announces Delayed Enforcement of Looming Supply Chain Requirements for Drugs Until 2024

Jones Day on 9/25/2023

With a November 2023 compliance deadline fast approaching, FDA publishes guidance explaining a one-year delayed enforcement of certain obligations, including interoperable, electronic, and package-level product tracing...more

California Follows the Lead of Other States in Heightening the Scrutiny of Health Care Transactions

Quarles & Brady LLP on 9/21/2023

California is taking steps to broaden its regulatory oversight of health care related transactions, joining a growing list of states that have recently either attempted to or have been successful in enacting similar...more

Artificial intelligence: Compliance considerations for provider organizations

Health Care Compliance Association (HCCA) on 9/11/2023

Artificial intelligence (AI) is nothing new to the healthcare industry, as many organizations and clinicians have utilized such tools in some capacity for many years. Imaging-related AI to support radiologists is not...more

Two new FDA Drug Supply Chain Security Act Guidances to help Pharmaceutical Supply Chain Partners Comply with the DSCSA’s move to...

Nelson Mullins Riley & Scarborough LLP on 9/1/2023

The DSCSA, enacted in 2013, requires entities in the pharmaceutical supply chain to implement security measures to prevent the introduction of counterfeit and illegitimate drugs into the market. One of these measures is the...more

FDA Publishes Informed Consent Final Guidance for Drug and Medical Device Clinical Investigations

Nelson Mullins Riley & Scarborough LLP on 8/16/2023

The U.S. Food and Drug Administration (FDA or the Agency) has issued the final guidance document, “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors” (Final Guidance). The...more

Minimizing the Fallout from Increasing FDA Clinical Holds

Nelson Mullins Riley & Scarborough LLP on 2/10/2023

With medical and scientific advances progressing at an exponential pace, FDA appears to be taking a more aggressive stance in imposing clinical holds on studies where adverse events are reported. Over the last several years,...more

FDA Issues Guidance on Drug and Biologic Submissions with Real-World Data and Real-World Evidence

Wilson Sonsini Goodrich & Rosati on 10/5/2022

Last month, the U.S. Food and Drug Administration (FDA) issued a final guidance on drug and biologic submissions to the agency that include real-world data (RWD) and real-world evidence (RWE). The procedural guidance aims to...more

FDA Concludes Software Pre-Cert Pilot Program, Noting Federal Legislative Action is Needed

Nelson Mullins Riley & Scarborough LLP on 10/3/2022

The U.S. Food and Drug Administration (“FDA” or the “Agency”) has issued a final report discussing the results of its Software Precertification Pilot Program (the “Pilot Program”). Importantly, the September 26, 2022 report...more

FDA Releases Draft Guidance for Sponsors on How to Comply with Study Data Standards When Submitting RWD-Sourced Study Data

Faegre Drinker Biddle & Reath LLP on 11/4/2021

The U.S. Food and Drug Administration (FDA) issued a draft guidance titled Data Standards for Drug and Biological Product Submissions Containing Real-World Data on October 21, 2021. The guidance provides the Agency’s thoughts...more

FDA’s Bendeka decision reverses approvals of Treanda generics

Hogan Lovells on 2/22/2019

Wednesday, FDA released a letter stating how the agency intends to implement the scope of orphan drug exclusivity awarded to Eagle Pharmaceuticals’ Bendeka (bendamustine HCl) by the D.C. Circuit Court in Eagle...more

New Brexit Q&A provides several examples in relation to the “placing on the EU market”of products including medical devices

Hogan Lovells on 2/7/2019

On 1 February 2019, the European Commission published a new Q&A document to give further guidance on the Notice to stakeholders-withdrawal of the United Kingdom and EU rules in the field of industrial products (“the Notice”)....more

European Commission publishes factsheet on medical devices and in vitro medical devices for non-EU and non-EEA competent...

Hogan Lovells on 1/8/2019

Introduction The European Commission has published a factsheet addressed to competent authorities of third countries....more

Life Sciences › Regulatory Oversight › Healthcare