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Innovation › Regulatory Oversight › Food and Drug Administration (FDA)

Epstein Becker & Green

Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast

Epstein Becker & Green on

Can food really be the prescription for better health? Discover how the “Food as Medicine” movement is reshaping health care and what it means for patients, providers, and the future of wellness. On this episode, special...more

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

FDA reviews go faster — but with less proof drugs are safer or more effective

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

For anyone concerned with the quality and safety of prescription medications, this may be an especially displeasing commentary from a pharmaceutical expert about drugs raced to approval now: “Some of them are really great,”...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Final Guidance on PDUFA Waivers, Reductions, and Refunds

Wilson Sonsini Goodrich & Rosati on

The Prescription Drug User Fee Act of 2017 (PDUFA VI) authorizes the U.S. Food and Drug Administration (FDA) to assess fees (PDUFA fees) when applicants submit new drug applications (NDAs). PDUFA fees are substantial. For...more

Hogan Lovells

Dietary Supplement Regulation Update: FDA Announces Public Meeting on Responsible Dietary Supplement Innovation; FDA Launches...

Hogan Lovells on

As a part of the Food and Drug Administration’s (FDA’s) initiative to modernize and reform dietary supplement oversight, FDA announced it will hold a public meeting on responsible innovation in dietary supplement...more

Hogan Lovells

FDA Announces Plans for Modernizing and Reforming Dietary Supplement Oversight and Issues Batch of Warning Letters Over Unlawful...

Hogan Lovells on

The Food and Drug Administration (FDA) recently announced a plan for “policy advancements with the goal of implementing one of the most significant modernizations of dietary supplement regulation and oversight in more than 25...more

Hogan Lovells

FDA Releases Plant and Animal Biotechnology Innovation Action Plan

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently released its Plant and Animal Biotechnology Innovation Action Plan (“Action Plan”). The Action Plan provides an overview of the key priorities FDA expects to pursue through...more

Hogan Lovells

USDA and FDA Announce Joint Oversight Over Cell Cultured Products

Hogan Lovells on

On Friday, November 16, 2018, the U.S. Department of Agriculture (USDA) Secretary Perdue and U.S. Food and Drug Administration (FDA) Commissioner Gottlieb announced a joint regulatory framework to oversee cell cultured...more

Troutman Pepper Locke

Real World Evidence: Implications and Challenges for Medical Product Communications in an Evolving Regulatory Landscape

Troutman Pepper Locke on

A confluence of factors is increasing and accelerating the digitization of large amounts of real world data (RWD) generated on individuals and patients. Originally published in Update magazine - August/September 2018....more

Hogan Lovells

There'll Be Some Changes Made: President Signs Prescription Drug and Biologic User Fee Reauthorization Act

Hogan Lovells on

On August 18, 2017, President Trump signed into law the FDA Reauthorization Act (FDARA). FDARA reauthorizes user fees paid to FDA to support regulatory review of innovator drugs and biologics, medical devices, generic drugs,...more

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