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Manufacturers Pharmaceutical Industry Food and Drug Administration (FDA)

Hogan Lovells

FDA promotes pre-approval for changes to devices, LDTs via PCCPs

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) has published new draft guidance on “Predetermined Change Control Plans for Medical Devices,” which describes the process by which device sponsors may seek FDA approval for...more

Searcy Denney Scarola Barnhart & Shipley

Exploring Treatment Options for Exactech Shoulder Issues: Surgery vs. Non-Surgical Approaches

The U.S. Food and Drug Administration (FDA) has issued a Safety Communication advising healthcare providers to stop implanting Equinoxe Shoulder System joint replacement devices manufactured by Exactech. The Safety...more

Goodwin

FDA Platform Technology Draft Guidance Highlights Utility of Obscure Patent Term Extension Provision

Goodwin on

As discussed in a prior Goodwin Alert, the US Food and Drug Administration (FDA) recently released Draft Guidance for designating a platform technology for drug development pursuant to § 560k of the Federal Food, Drug, and...more

White & Case LLP

Three Drug Pricing Litigation Issues to Watch in the Second Half of 2024

White & Case LLP on

It has been a busy year for issues related to drug pricing, and with the election around the corner, litigation issues that have been developing over the last few years are likely to be a key focus for the second half of...more

Gardner Law

FDA Drafts Guidance on Correcting “Misinformation”

Gardner Law on

The U.S. Food and Drug Administration (FDA) recently released draft guidance on how and when medical device manufacturers and pharmaceutical companies can respond to misinformation about their products online. While not yet...more

Hogan Lovells

Safe harbor for voluntary corrections of drug or device “misinformation” clarified in FDA guidance

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) issued the revised draft guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs,” which clarifies how firms can address misinformation about their...more

Faegre Drinker Biddle & Reath LLP

Worried About Misinformation? FDA Is Too. Here’s What You Should Know.

On July 9, 2024, the Food and Drug Administrations (FDA) replaced a 10-year-old draft industry guidance on misinformation and social media information on prescription drugs and medical devices. The new guidance assists...more

Epstein Becker & Green

FDA Issues Long-Anticipated Draft Guidance on Diversity Action Plans

Epstein Becker & Green on

The Food and Drug Omnibus Reform Act of 2022 (“FDORA” or the “Act”), signed into law on December 29, 2022, required, in part, drug and device manufacturers to submit Diversity Action Plans to the U.S. Food and Drug...more

Hogan Lovells

FDA summarizes LDT rule requirements in new compliance guide

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) announced yesterday a “Small Entity Compliance Guide” (SECG) for Laboratory Developed Tests (LDTs), aiming to assist small entities in complying with FDA’s LDT final rule, which...more

Holland & Knight LLP

Orange Book Concerns Pick Up as Yet Another Issue for Pharmaceutical Manufacturers

Holland & Knight LLP on

Pharmaceutical manufacturers are increasingly finding themselves defending decisions to list in the U.S. Food and Drug Administration's (FDA) Orange Book patents that they assert are associated with their products. The...more

Troutman Pepper

FDA Issues Final Rule on Regulation of Laboratory Developed Tests

Troutman Pepper on

After many years of anticipation and various congressional and agency proposals, on May 6, the Food and Drug Administration (FDA) published its final rule titled "Medical Devices; Laboratory Developed Tests." The final rule...more

Arnall Golden Gregory LLP

The Fixx: FDA Clarifies Distinctions Between Medical Device Servicing and Remanufacturing

The 1980s British rock band, The Fixx, comes to mind when one reads the Food and Drug Administration’s recently issued “Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug...more

Hogan Lovells

FDA Platform Technology Designation Program aims to speed development of drugs, biological products

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) has issued draft guidance on its “Platform Technology Designation Program,” which aims to streamline drug development, manufacturing, and marketing application review for products...more

Hogan Lovells

FDA finalizes guidance on “Remanufacturing” vs “Servicing”

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) has finalized its guidance on “Remanufacturing of Medical Devices,” clarifying the point when manipulation or repair of a medical device becomes “remanufacturing” as opposed to...more

Jones Day

Canadian Drug Importation May Undermine Intellectual Property Protection

Jones Day on

The Situation: Earlier this year, Florida became the first state to receive authorization for its Section 804 Importation Program ("SIP") from the U.S. Food and Drug Administration ("FDA"). This initial step toward the legal...more

Hissey, Mulderig & Friend, PLLC

Women With Broken Paragard Copper IUDs May Qualify to File a Lawsuit

Women whose Paragard copper IUD broke during removal or while being implanted may be eligible to file a lawsuit and receive compensation for their injuries. Thousands of women who were injured by broken Paragard IUDs have...more

Jones Day

California Supreme Court Will Review Novel Negligence Theory for Pharmaceutical Manufacturers

Jones Day on

The Situation: The California Supreme Court recently granted review of a California Court of Appeal decision, Gilead Life Sciences, Inc. v. The Superior Court of the City and County of San Francisco, that made waves in the...more

Epstein Becker & Green

Unpacking Averages: Assessing the Products Included in FDA's Voluntary Malfunction Summary Reporting Program

At the end of 2022, FDA published a draft guidance on Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers. The draft guidance explains several aspects of the VMSR Program, including FDA’s approach to...more

Sheppard Mullin Richter & Hampton LLP

FDA Makes Good on Its Promise to Regulate Laboratory-Developed Tests

Yesterday, the Food & Drug Administration (“FDA” or “the Agency”) issued a highly anticipated – and highly controversial – final rule, which rolls out a four-year, five-stage plan that will phase out the Agency’s previous...more

Jones Day

FDA Proposes Updated Guidance Concerning Cybersecurity of Medical Devices

Jones Day on

The U.S. Food and Drug Administration ("FDA") has proposed updated guidance, intended to assist individuals in meeting the cybersecurity requirements for FDA medical device submissions....more

Troutman Pepper

New FDA Guidance on AI and Medical Products

Troutman Pepper on

n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more

McDermott Will & Emery

Imported Drugs: (Possibly) Coming Soon to a State Near You

In recent years, states have been exploring innovative avenues to address rising healthcare costs and ensure access to affordable medication for their residents. One idea gaining traction involves pursuing authorization from...more

Oberheiden P.C.

A 4-Point Guide for Pharmaceutical Whistleblowers

Oberheiden P.C. on

There are many junctures in the U.S. healthcare system that enable fraudulent activities, and one of the biggest has to do with pharmaceutical companies. The U.S. Food and Drug Administration (FDA) and the Department of...more

Array

eDiscovery and ANDA Litigation: Unique Timelines, Processes, and Workflows

Array on

ANDA litigation is a high-stakes niche of pharmaceutical law that presents unique challenges not only for lawyers, but also for eDiscovery practitioners. Here’s why: under the Drug Price Competition and Patent Term...more

Jones Day

FDA's Final Device Manufacturing Rule—Not Quite Harmonious With Status Quo

Jones Day on

Amending prior requirements, medical device manufacturers and importers have two years to comply with FDA's Quality Management System Regulation final rule, a similar approach to prior good manufacturing practices but with...more

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