News & Analysis as of

Research and Development Draft Guidance

Gardner Law

FDA's View on Cannabis

Gardner Law on

The U.S. Food and Drug Administration (FDA) is continuing to support clinical research for cannabis and psychedelic drug development. On the heels of publishing its first draft guidance on clinical trials involving...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: April 2024

Arguing that the National Science Foundation (NSF) was “intricately involved” when it made a $1.125 million fixed amount subaward, Oklahoma University (OU) objected to a recent finding by auditors for the NSF Office of...more

Foley & Lardner LLP

Clinical Research: FDA Issues Draft Guidance on Informed Consent

Foley & Lardner LLP on

The U.S. Food and Drug Administration (FDA), in collaboration other agencies, recently published draft guidance (Guidance) on effectively presenting key information regarding informed consent in FDA-regulated clinical...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

McDermott Will & Emery

Special Report: Developments in UK Life Sciences – Spring Update 2022

McDermott Will & Emery on

MHRA LAUNCHES UK CLINICAL TRIAL REGULATION CONSULTATION - The UK Government, through the Medicines and Healthcare Products Regulatory Agency (MHRA) (the medicines and medical device regulator in the United Kingdom),...more

Manatt, Phelps & Phillips, LLP

New FDA Draft Guidance Encourages Industry Focus on Improving Clinical Trial Diversity

Last week, in the midst of the Biden Administration’s coordinated release of more than 90 “Equity Action Plans” by various federal agencies, the FDA issued a new draft guidance on enhancing clinical trial diversity. In a...more

Hogan Lovells

ICO consults on new guidance for conducting scientific research under the UK GDPR

Hogan Lovells on

Research and development, innovation, product and service improvement, AI design and deployment...these are key commercial drivers for the successful modern business. They also underpin technological, medicinal, and other...more

McDonnell Boehnen Hulbert & Berghoff LLP

FDA Issues Final and Draft Guidances on Biosimilar Development under BPCIA

In September, the U.S. Food and Drug Administration issued Final Guidance entitled "Questions and Answers on Biosimilar Development and the BPCI Act: Guidance for Industry," and Draft Guidance entitled "New and Revised Draft...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 9. In This Month’s E-News: September 2021

Report on Research Compliance 18, no. 9 (September, 2021) - A former Harvard Medical School and Massachusetts General Hospital (MGH) researcher who was the principal investigator on a 2014 NIH award of $939,495.27 and...more

White & Case LLP

JFTC and METI issued Guidelines for Business Collaboration with Startups

White & Case LLP on

On March 29, 2021, the Japan Fair Trade Commission ("JFTC") and Ministry of Economy, Trade and Industry ("METI") issued Guidelines for Business Collaboration with Startups ("Guidelines") for the purpose of promoting open...more

White & Case LLP

JFTC and METI Proposed Guidelines for Business Collaboration with Startups

White & Case LLP on

On December 23, 2020, the Japan Fair Trade Commission ("JFTC") and Ministry of Economy, Trade and Industry ("METI") proposed a draft of Guidelines for Business Collaboration with Startups ("Guidelines") for the purpose of...more

Saul Ewing LLP

FDA Sends CBD Enforcement Policy to OMB, Issues Cannabis Clinical Research Draft Guidance, and Submits CBD Testing Report to...

Saul Ewing LLP on

This summer has been a busy one in the cannabis and cannabis-derived products spaces. On Wednesday, July 22, 2020, the U.S. Food and Drug Administration (FDA or the Agency) sent to the White House Office of Management and...more

Wilson Sonsini Goodrich & Rosati

FDA Outlines Considerations for the Development and Labeling of Companion Diagnostics for Use with a Specific Group or Class of...

Recently, the U.S. Food and Drug Administration, or FDA, issued a draft guidance (the guidance) outlining considerations for the development and labeling of in vitro companion diagnostics to support indicated uses for...more

McDermott Will & Emery

FDA and OHRP Issue Joint Draft Guidance on IRB Written Procedures

McDermott Will & Emery on

On August 2, 2016, the US Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) jointly issued draft guidance concerning Institutional Review Board (IRB) written procedures. The guidance...more

14 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide