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Food Manufacturers Pharmaceutical Industry

K&L Gates LLP

An Overview of the US Food and Drug Administration's Legislative Goals (Part I)

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In anticipation of the US Food and Drug Administration (FDA) budget request for Fiscal Year (FY) 2025, this alert provides an overview of the agency’s most recent priorities as outlined in FDA’s FY 2024 budget, found here....more

Davis Wright Tremaine LLP

Project W: Uncovering a Promising Sector in Climate Tech

The food and ag sectors are tied to nearly a quarter of all global greenhouse gas emissions. However, those sectors receive disproportionately less climate tech venture funding. Beatriz Franco and Maya Benami of Vita Vera...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

Foley & Lardner LLP

One Year of Action Since President Biden’s Executive Order on Competition

Foley & Lardner LLP on

Earlier this month — July 9, 2022 — marked the one-year anniversary of President Biden’s Executive Order on Promoting Competition in the American Economy (Executive Order). The Executive Order was notable in its breadth and...more

Oberheiden P.C.

FDA Inspection Audit? What to Expect

Oberheiden P.C. on

The Food and Drug Administration is the federal agency charged with ensuring the safety of food, medication and other consumable products. In carrying out its duties, the FDA conducts both inspections of plants 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

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - March 2020

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug Practice....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

Sheppard Mullin Richter & Hampton LLP

FDA Year in Review: A Shifting Regulatory Landscape

The FDA actions that dominated 2019 demonstrated a shifting regulatory landscape for certain product types, such as e-cigarettes, foods and supplements containing cannabidiol (CBD), and digital health / machine learning...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

Robins Kaplan LLP

Financial Daily Dose 8.27.2019 | Top Story: OK Judge Hits Johnson & Johnson With $572 Million Fine in Opioid Trial

Robins Kaplan LLP on

A bad day for J&J in Oklahoma at the close of the state’s trial against Johnson & Johnson means that the company’s on the hook for upwards of $572 million for its role in the opioid crisis that’s decimated swaths of the...more

BakerHostetler

FDA and Pharmacy Weekly Digest - August 2019 #3

BakerHostetler on

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

Hogan Lovells on

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

BakerHostetler on

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

BakerHostetler

BakerHostetler FDA and Pharmacy Weekly Digest - November 2018 #2

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Food/Dietary Supplements - FDA Releases Report on Food-borne Illness – The FDA issued a report on the prevalence of food-borne illness risk factors in fast-food and full-service restaurants. ...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

Dechert LLP

U.S.-Russia Business Climate Likely to Change Under Trump Presidency

Dechert LLP on

Donald Trump’s election has the potential to significantly reshape U.S.-Russia relations, but whether any change occurs will depend largely on his willingness to offer Russia a clean slate and whether the U.S. Congress...more

Morrison & Foerster LLP

Significant Liberalization of Foreign Investment Rules in India

On June 20, 2016, the Indian government, in an effort to open up the Indian economy and bring in much-needed foreign capital, announced a radical liberalization of the foreign direct investment (FDI) rules by liberalizing...more

Morgan Lewis

India Heralds Radical Change in FDI Policy

Morgan Lewis on

With amendments to its foreign direct investment policy, India seeks to attract foreign investment in the country. On June 20, the government of India (GOI) issued a press release announcing major changes to its foreign...more

Bradley Arant Boult Cummings LLP

The Government Whittles Away at Life Sciences Patents

The current U.S. Supreme Court has been noted for its hostility to patent holders in general, but the Supreme Court has been especially hostile to any sort of life sciences or software invention. The Court has attempted to...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

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