News & Analysis as of

Medical Devices Food Safety

Alston & Bird

Health Care Week in Review: CMS Finalizes FY 2025 Payment Rules for Inpatient Hospitals, Inpatient Rehab Facilities, Inpatient...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Goodwin

The Long (Un)Winding Road: FDA Maps Out How the End of the Public Health Emergency Will Impact its COVID-19 Policies

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Since the beginning of the COVID-19 pandemic, the US Food and Drug Administration (FDA or the Agency) has issued more than 80 guidance documents describing flexibilities that would be available to manufacturers of medical...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

BakerHostetler

FDA and Pharmacy Weekly Digest - October 2020 #1

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FDA Released Food Traceability Proposed Rule – The United States Food and Drug Administration (FDA) is proposing to establish additional traceability recordkeeping requirements for manufacturers, processors, packers or...more

BakerHostetler

FDA and Pharmacy Weekly Digest - July 2020 #2

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FDA Plans to Restart On-Site Inspections the Week of July 20 -Commissioner Hahn announced the goal of restarting inspections, which were halted due to COVID-19. The FDA has developed a COVID-19 Advisory Rating system to...more

Butler Snow LLP

Development of the Food & Drug Administration

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The Food & Drug Administration is perhaps the most important, ubiquitous agency in the daily lives of modern American consumers. Consumers rely on the FDA to verify the safety and effectiveness of $2.6 trillion in food,...more

BakerHostetler

FDA and Pharmacy Weekly Digest - April 2020 #3

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Food - FDA Extended Comment Period for Rule on Food Standards – The comment period on the proposed rule was extended until July 20. The proposed rule, “Food Standards; General Principles and Food Standards Modernization,”...more

BakerHostetler

FDA and State Boards of Pharmacy React to Coronavirus – March 27 Update

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The U.S. now has the most confirmed coronavirus cases in the world, and the FDA and state boards of pharmacy are issuing daily guidance on how to stop the spread or join in the fight through relaxed standards or expedited...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 #4

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Food/Dietary Supplements - FDA Calls for Improved Practices in the Papaya Industry – The FDA reported trends in outbreaks of Salmonella in fresh papaya. ...more

BakerHostetler

FDA and Pharmacy Weekly Digest - July 2019 #5

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Food/Dietary Supplements - FDA Suspends Food Facility Registration – The FDA announced the suspension of a Texas-based seafood producer....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

BakerHostetler

BakerHostetler FDA and Pharmacy Weekly Digest - November 2018 #3

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Food/Dietary Supplements - 2016 Foodborne Illness Report Released – The Food Safety Analytics Collaboration released a new report titled “Foodborne illness source attribution estimates for 2016 for Salmonella, Escherichia...more

BakerHostetler

BakerHostetler FDA and Pharmacy Weekly Digest

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Food/Dietary Supplements - FDA Investigation Into Salmonella Outbreak – The Food and Drug Administration (FDA) announced that it is investigating a multistate outbreak of Salmonella enteritidis it believes is linked to shell...more

Akin Gump Strauss Hauer & Feld LLP

A Client's Guide to FDA Inspections

A Food and Drug Administration (FDA) inspector has just knocked on your door and announced that he or she will now inspect your facility. What happens before, during and after this inspection, and what should your firm do to...more

Akin Gump Strauss Hauer & Feld LLP

FDA Announces Import Staffing Change at International Mail Facilities

Earlier this month, The Washington Post reported that Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced that he was reallocating three dozen employees to international mail facilities (IMF), as well as...more

Hogan Lovells

International Product Liability Review - Issue 65

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The International Product Liability Review provides quality updates and comment from around the world on legal developments in the field of product liability and product safety. ...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

K&L Gates LLP

Global Food, Drugs, Medical Devices and Cosmetics Newsletter

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Welcome - We are pleased to provide you with the Spring edition of the Global Food, Drugs, Medical Devices and Cosmetics newsletter. As stated in our inaugural issue, this newsletter provides updates on important...more

Polsinelli

FDA Deputy Commissioner Details Agency’s Priorities In Recent Speech

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In This Issue: - Snapshot of the Agency: FDA-regulated products - Recent Public Health Milestones - Innovative Programs at FDA ..A. FDA has a number of programs intended to speed the availability of...more

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