News & Analysis as of

Food and Drug Administration (FDA) Regulatory Oversight Research and Development

DLA Piper

CRLs Made Public: What FDA’s New Policy Means For the Drug Industry

DLA Piper on

The US Food and Drug Administration (FDA) recently announced the availability of the first-ever centralized database of Complete Response Letters (CRLs) on openFDA, one of several steps taken under the agency’s initiatives to...more

Troutman Pepper Locke

HHS Proposes Rescheduling Cannabis to Schedule III – What It Means for the Industry

Troutman Pepper Locke on

It has been widely reported and confirmed publicly that, on August 29, the U.S. Department of Health and Human Services (HHS) sent a letter to the Drug Enforcement Administration (DEA) recommending that cannabis be moved from...more

Patrick Malone & Associates P.C. | DC Injury...

$1 billion+ may seem like a lot of money. It still can’t resolve many questions.

Although lawsuits can result in needed financial support and welcome recognition of harms suffered by patients seeking medical services, the civil justice system has its limits. They showed in cases in the news in which...more

Bradley Arant Boult Cummings LLP

Hemp Poised for Resurgence Following Farm Bill's Passage - The National Law Journal

Centuries after American colonists were required by law to grow hemp, and decades after it was then outlawed by Congress, one of the nation’s oldest and most versatile crops is poised for a resurgence. The 2018 Farm Bill,...more

Hogan Lovells

Institutional Review Board “Checklist” offers tool to help protect clinical trial participants

Hogan Lovells on

On May 17, HHS’s Office for Human Research Protections (OHRP) and FDA issued a joint, final guidance on written procedures for institutional review boards (IRBs). ...more

Hogan Lovells

FDA and OHRP Finalize Joint Guidance on IRB Meeting Minutes

Hogan Lovells on

Ongoing Effort to Harmonize Human Subject Research Regulations The U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP), both part of the Department of Health and Human Services (HHS),...more

Ballard Spahr LLP

Obama Signs 21st Century Cures Act, Adding $6.3 Billion For Medical Research

Ballard Spahr LLP on

The Cures Act aims to increase the speed by which new drugs are brought to market by streamlining clinical trials, allowing the use of patient data in the regulatory review process, and modernizing U.S. Food and Drug...more

7 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