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Regulatory Standards Manufacturers

Baker Donelson

Six Sizzling Ways to Beat the OSHA Heat This Summer

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The summer heat is in full swing and so are ramped-up compliance efforts from OSHA. This alert provides you with six quick tips to help avoid and minimize any "heat" from OSHA this summer....more

Searcy Denney Scarola Barnhart & Shipley

Understanding the Manufacturing Process of Eye Drops and How Contamination Can Occur

The U.S. Food and Drug Administration (FDA) has recently identified several brands of eye drops that were sold with contaminants. These contaminants—which were introduced into the affected eye drops during the manufacturing...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

Womble Bond Dickinson

WBD Energy Survey and the Innovation Interchange: The Energy Transition for Non-Energy Companies

Womble Bond Dickinson on

Energy is the cornerstone of our society and its availability, or lack thereof, touches every corner of our lives and impacts every business, regardless of sector. The availability of affordable energy on-demand is essential...more

Pillsbury - Internet & Social Media Law Blog

The EU and UK Introduce New IoT Security Standards

The FCC’s recent introduction of a new Voluntary Cybersecurity Labelling Program for consumer Internet of Things (IoT) products reflects the continued desire by U.S. regulators to bolster the security of the ever-increasing...more

Alston & Bird

PFAS Primer Quarterly Update: 2023 Q4 – Setting the PFAS Standard

Alston & Bird on

In the latest edition of the PFAS Primer Quarterly Update, our roundup of regulatory, litigation, and scientific actions involving PFAS. This quarter, the OMB reviews RCRA and CERCLA PFAS rules, Washington State wants more...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Orrick, Herrington & Sutcliffe LLP

Modified Liability for AI: EU Review of AI Liability Rules

The EU AI Act, which is progressing towards adoption by the end of 2023, will be complemented by an update to the European civil liability rules applicable to AI-related claims. Towards the end of 2022, the EU Commission...more

Morgan Lewis - Well Done

Cosmetics Regulations Getting a Makeover: FDA Announces Listening Session on Cosmetic Product GMPs

FDA recently published a Federal Register notice announcing a public listening session on good manufacturing practices (GMPs) for cosmetic products under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which...more

Faegre Drinker Biddle & Reath LLP

The Omnibus Appropriations Act Grants FDA Formal Authority to Require Cybersecurity Action by Medical Device Manufacturers

Cyberattacks affecting internet-connected medical devices like insulin pumps, intracardiac defibrillators, mobile cardiac telemetry, pacemakers and intrathecal pain pumps have increased in recent years. And such attacks show...more

Jenner & Block

PFAS in Consumer Products

Jenner & Block on

Developing a Proactive and Strategic Game Plan - Per- and polyfluoroalkyl substances (PFAS) in consumer products continue to be in the regulatory and litigation spotlight in 2023. Manufacturers and downstream businesses...more

Latham & Watkins LLP

European Commission Releases Communication on the Green Deal Industrial Plan

Latham & Watkins LLP on

The Plan aims to “simplify, accelerate and align incentives to preserve the competitiveness and attractiveness of the EU as an investment location for the net-zero industry”. On 1 February 2023, the European Commission...more

Jenner & Block

Client Alert: PFAS in Consumer Products: Developing a Proactive and Strategic Game Plan

Jenner & Block on

Per- and polyfluoroalkyl substances (PFAS) in consumer products continue to be in the regulatory and litigation spotlight in 2023. Manufacturers and downstream businesses should be actively preparing to comply with the...more

Hogan Lovells

Can sterile drug manufacturers implement EU GMP Annex 1 requirements before August?

Hogan Lovells on

In August 2022, the European Commission published a revision to Annex 1 “Manufacture of Sterile Medicinal Products” in EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines that will significantly impact...more

Butler Snow LLP

Trust the reProcess? A Practical and Legal Overview of Reprocessing Single-Use Medical Devices in the United States

Butler Snow LLP on

Allow me to set the stage. Our plaintiff claims he felt a nagging pain in his shoulder for months and finally went to see the local orthopedic surgeon. The surgeon apparently informed him that the tissue and cartilage in his...more

Faegre Drinker Biddle & Reath LLP

Not Just a Rubber Stamp: FDA Revises Its 510(k) Refuse to Accept Policy

Is the decision to submit a 510(k) application versus a Premarket Application (PMA) at the sole discretion of a medical device manufacturer? The answer is not always clear to product liability lawyers, judges, and juries. FDA...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Proposes Amendments to Medical Device Quality System Regulation

On February 22, 2022, the Food and Drug Administration (FDA) proposed a long-awaited rule to amend its Quality System Regulation (QSR), which is codified at 21 CFR Part 820 and sets forth current good manufacturing practice...more

Jones Day

2022 & Beyond: Continued Challenges in the Automotive Supply Chain

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While our inboxes are flooded on a daily basis with news about how the pandemic has created supply chain and commodities issues, global organizations must think about more than just near-term issues. Although the pandemic...more

BakerHostetler

Made in USA, Part Two – How Far Back Do You Have to Look?

BakerHostetler on

Prior to the new year, we blogged about how the Federal Trade Commission’s (Commission) decision to codify its Made in USA (MUSA) guidance into a rule – and the accompanying threat of civil penalties – makes it all the more...more

Faegre Drinker Biddle & Reath LLP

Going Paperless: What Manufacturers Need to Know Before Digitizing Warnings

By the time the COVID-19 pandemic began, society was well into the so-called “Digital Age,” relying heavily on electronic communications, apps, websites, and the like to go about daily activities. Everything from ordering...more

Proskauer - Life Sciences

U.S. Medical Device Manufacturers Should Take Note of New European Medical Device Regulations

The European Union has been a leader in recent years when it comes to regulatory reform intended to protect individuals’ privacy, safety, and health. As Europe leads the way, regulators in the United States often follow suit...more

Katten Muchin Rosenman LLP

New FTC Rules Leave Contemporary NAD/NARB Questions Unanswered - Kattison Avenue Fall 2021 | Issue 7

This summer, the Federal Trade Commission (FTC) published final rules codifying its long-running standard for “Made in USA” product labels. The Commission also announced its 2022 timeline for rolling out a new version of the...more

Manatt, Phelps & Phillips, LLP

FTC Finalizes Made in USA Labeling Rule

The Federal Trade Commission (FTC) has finalized the Made in USA Labeling Rule, which codifies its long-standing enforcement policy requiring that marketers making unqualified Made in USA claims on labels be able to prove...more

Faegre Drinker Biddle & Reath LLP

New FDA Policy on Homeopathic Drugs Survives Preliminary Injunction Appeal

The FDA’s recent policy shift regarding homeopathic drugs was recently supported by the D.C. Circuit Court of Appeals in MediNatura v. FDA, No. 20-5341 (D.C. Cir. 2021), when it upheld the denial of a preliminary injunction...more

Robinson+Cole Manufacturing Law Blog

OSHA Publishes Updated COVID-19 Guidance

On June 21, 2021, OSHA made big news by publishing its COVID-19 Emergency Temporary Standard for the Healthcare Industry (ETS). While the ETS does not apply to most manufacturing facilities, OSHA also updated its general...more

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