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Morgan Lewis - As Prescribed

FDA’s Recent Guidance on Accelerated Approval and Implications for Rare Diseases

Morgan Lewis - As Prescribed on

In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community....more

Akin Gump Strauss Hauer & Feld LLP

FDA Unveils Draft Guidance on Developing Drugs and Biological Products for Weight Reduction

Akin Gump Strauss Hauer & Feld LLP on

On January 7, the FDA made available draft guidance on the development of drugs and biological products for weight reduction within the Center for Drug Evaluation and Research intended for reduction and long-term maintenance...more

Verrill

Don’t Wait – CMS Expects Hospitals to Take Action on Informed Consent for Certain Exams and Procedures

Verrill on

Hospitals should not delay in reviewing and revising their surgical informed consent forms and policies. On April 1, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued new guidance regarding informed consent...more

Epstein Becker & Green

Updated Requirements for Informed Consent: HHS Issues New Guidance on Sensitive Exams

Epstein Becker & Green on

On April 1, 2024, the U.S. Department of Health and Human Services (“HHS”) released new guidance which requires hospitals to obtain informed consent from patients before practitioners, or medical or other students, perform...more

Goodwin

A Practical Look at OIG’s New Compliance Guidance

Goodwin on

On November 6, 2023, for the first time in 15 years, HHS OIG issued a new reference guide for the health care compliance community – the General Compliance Program Guidance, or GCPG. While the GCPG does not set new legal...more

Akerman LLP - Health Law Rx

The FTC Sends Another Warning to Digital Healthcare Platforms About Use of Tracking Pixels

Akerman LLP - Health Law Rx on

The Federal Trade Commission (FTC) continues to prioritize the protection of consumers’ digital health information. The agency has demonstrated this commitment through enforcement actions against GoodRx and BetterHelp for...more

Robinson+Cole Health Law Diagnosis

AdvaMed Updates its Code of Ethics

Robinson+Cole Health Law Diagnosis on

On March 24th, 2022, the Advanced Medical Technology Association’s (AdvaMed) Board of Directors approved updates to the AdvaMed Code of Ethics (Code), which provides guidance to the health care industry on interactions...more

King & Spalding

U.S. and EU Regulators and Institutions Issue Guidance on Clinical Trial Conduct during COVID-19 Pandemic

King & Spalding on

The Food and Drug Administration (“FDA”) as well as the European Medicines Agency (“EMA”) and the national Heads of Medicines Agencies (“HMA”) issued new guidance for industry sponsors, investigators, and Institutional Review...more

Akin Gump Strauss Hauer & Feld LLP

[Podcast] DOJ’s New Guidance on Evaluating Compliance Programs: What You Need to Know

Akin Gump Strauss Hauer & Feld LLP on

In this episode, Akin Gump health care and life sciences counsel Taylor Jones and Matt Wetzel discuss the Justice Department’s recent guidance on evaluation of corporate compliance programs. Among the topics covered: •...more

Latham & Watkins LLP

MHRA Releases No-Deal Brexit Guidance for Life Sciences Companies

Latham & Watkins LLP on

The guidance provides helpful clarity on key regulatory changes impacting life sciences companies in the event of a no-deal Brexit. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published a...more

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