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Food Manufacturers Medical Devices

Jones Day

FDA on Board With Continuing Remote Inspections

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The Food and Drug Administration ("FDA") recently issued revised draft guidance on remote regulatory assessments ("RRAs")—voluntary or mandatory examinations of food, drug, device, and tobacco establishments and/or their...more

McDermott Will & Emery

Special Report - 2022 FDA Year in Review

As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more

Tucker Arensberg, P.C.

Dispute Between Telehealth Giants Heats Up

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Teladoc has sued competitor Amwell over patent claims in the U.S. District Court for the District of Delaware. Teladoc is accusing Amwell of infringing on its patents related to telehealth carts, a digital scope and...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Patent Prosecution Tool Kit: Patent Term Extension

Patent term extension (PTE) is available under the 1984 Drug Price Competition and Patent Restoration Act, also known as the Hatch-Waxman Act (The Act). The Act allows the extension of the term of a patent claiming a product...more

Morgan Lewis

CARES Act Provisions Impact Drug, Device, and Food Manufacturers and Suppliers

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The $2 trillion economic stimulus package laid out in the Coronavirus Aid, Relief, and Economic Security (CARES) Act includes $11 billion in appropriations for vaccines, therapeutics, and other medical needs, and $34.9...more

Wilson Sonsini Goodrich & Rosati

Wilson Sonsini Digest of FDA Actions Related to COVID-19

Many global markets have been impacted by COVID-19, including the medical product and food industries. Both sectors are particularly critical as medical products are relied upon to help abate the disease and as communities...more

BakerHostetler

FDA and Pharmacy Weekly Digest - December 2019 #1

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Food/Dietary Supplements - FDA Issues Warning Letters to Companies Selling Cannabidiol-Containing Products – The FDA announced it issued warning letters to 15 companies “for illegally selling products containing cannabidiol...more

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Ninth Annual Pharmaceutical and Medical Device Seminar

On October 22, 2019, Skadden hosted our Ninth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York, which focused on U.S. enforcement issues companies face throughout the industry. The key...more

BakerHostetler

FDA and Pharmacy Weekly Digest - September 2019 #1

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Food/Dietary Supplements - FDA Will Hold Public Meeting on Food Standards of Identity – The meeting will be held on Sept. 27, 2019, and is intended “to give interested parties an opportunity to discuss FDA’s effort to...more

BakerHostetler

FDA and Pharmacy Weekly Digest - August 2019 #3

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Food/Dietary Supplements - FDA Remarks at National Industrial Hemp Council 2019 Hemp Business Summit – The Principal Associate Commissioner for Policy for the FDA stated, “We’ve seen rapidly growing interest in marketing...more

Hogan Lovells

New FDA draft guidance on voluntary recalls highlights importance of recall initiation plans

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On April 23, FDA issued draft guidance entitled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,” which aims to clarify how firms in a product distribution chain should prepare to facilitate timely initiation...more

Akin Gump Strauss Hauer & Feld LLP

A Client’s Guide to FDA Recalls

Recent FDA Recall Highlights & Developments - • The agency finalized Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Guidance for Industry and FDA Staff, providing recommendations regarding the...more

BakerHostetler

BakerHostetler FDA and Pharmacy Weekly Digest - December 2018 #4

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Food/Dietary Supplements - FDA Commissioner Announces Ongoing Services During the Partial Government Shutdown – The FDA released a statement that certain programs would continue to run during the shutdown. ...more

Spilman Thomas & Battle, PLLC

Product Lines - Toxic Torts and Product Liability Insights - Issue 3, 2018

Welcome to the third issue of Product Lines – our quarterly e-newsletter that focuses on toxic torts and products liability issues. For this edition, we are reporting on several important and timely legal issues. As you...more

Akin Gump Strauss Hauer & Feld LLP

A Client's Guide to FDA Recalls

Product recalls are critical events for firms that produce food and medical products. The lives and health of patients and consumers can be at stake. Companies risk enforcement action by the Food and Drug Administration...more

Foley Hoag LLP

Product Liability Update: October 2016

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Massachusetts Federal Court Dismisses Putative Class Action Because Defendant’s Unconditional Checks for Named Plaintiff’s Maximum Damages, Even Though Uncashed, Mooted Suit - In Demmler v. ACH Food Companies, Civil No....more

Arnall Golden Gregory LLP

US FDA Updates for Irish and Northern Irish Companies

AGG produces a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from our Washington, DC office. The June 2015 update is now available....more

Bergeson & Campbell, P.C.

EP Committee Study on Legislative Areas of the TTIP Addresses Nanomaterials

The European Parliament (EP) Committee on Environment, Public Health, and Food Safety (ENVI) has posted a study entitled ENVI Relevant Legislative Areas of the EU-US Trade and Investment Partnership Negotiations (TTIP). The...more

K&L Gates LLP

Global Food, Drugs, Medical Devices and Cosmetics Newsletter - 3rd Edition

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Welcome - We are pleased to provide you with the Fall edition of the Global Food, Drugs, Medical Devices and Cosmetics newsletter. This newsletter provides updates on important issues and developments across these...more

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