News & Analysis as of

Manufacturers Regulatory Reform

Arnall Golden Gregory LLP

“Back in the U.S.A.”: FDA Launches PreCheck Program to Boost Domestic Drug Manufacturing

Chuck Berry’s 1959 hit, “Back in the U.S.A.” came to mind as we reviewed the Food and Drug Administration’s recent move to bolster the resilience of the U.S. pharmaceutical supply chain by introducing the FDA PreCheck...more

Mintz - Health Care Viewpoints

FDA in Flux — August 2025 Newsletter

Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies....more

Bergeson & Campbell, P.C.

EPA Accelerates Review of LVEs

The U.S. Environmental Protection Agency (EPA) announced on August 11, 2025, the results of process improvements to accelerate the review of Low Volume Exemptions (LVE) in the Toxic Substances Control Act (TSCA) New Chemicals...more

Katten Muchin Rosenman LLP

Fast-Lane Approval to Boost U.S. Drug Manufacturing and Supply Chain Security

On August 7, 2025, the Food and Drug Administration announced a voluntary “FDA Pre-Check” program to encourage and expedite domestic drug manufacturing by offering qualifying facilities a more predictable, risk-based...more

Morgan Lewis - As Prescribed

FDA’s New Priority Voucher Program for Drug Developers Ties Incentives to Defined National Interests

The US Food and Drug Administration recently announced the launch of a regulatory incentive program pilot program, the Commissioner’s National Priority Voucher Program (CNPVP), designed to reward drug and biologic sponsors...more

Foley Hoag LLP

FDA Launches PreCheck Program to Accelerate Onshoring of Drug Manufacturing Facilities

Foley Hoag LLP on

Key Takeaways: - The FDA PreCheck program, launched in response to Executive Order 14293, is designed to streamline and expedite the construction and approval of domestic drug manufacturing facilities, aiming to reduce...more

Husch Blackwell LLP

NHTSA Grants First-Ever U.S. Exemption for Purpose-Built Robotaxi Fleet: Key Takeaways for the AV Industry

Husch Blackwell LLP on

The National Highway Traffic Safety Administration (NHTSA) has granted Amazon’s Zoox Inc. a landmark exemption for its U.S.-manufactured, purpose-built autonomous vehicles (AVs). This decision allows Zoox to deploy robotaxis...more

Hogan Lovells

The digital makeover of EU product legislation

Hogan Lovells on

The European Commission unveiled in May the fourth Omnibus package (“Omnibus IV”), part of its broader Single Market Strategy to modernise and simplify EU product legislation in line with the digital age. Omnibus IV aims to...more

Hogan Lovells

Key takeaways – UK MHRA’s response to consultation on ‘Medical Devices Regulations: Routes to market and in vitro diagnostic...

Hogan Lovells on

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its responses to the consultation on Medical Device Regulations: Routes to market and in vitro diagnostic devices carried out last year....more

Holland & Knight LLP

A MOSAIC of Changes: Recent FAA Actions Promote Advanced Air Mobility

Holland & Knight LLP on

At the Experimental Aircraft Association's (EAA) annual EAA AirVenture Oshkosh, Wisconsin, on July 22, 2025, U.S. Department of Transportation Secretary Sean Duffy and Federal Aviation Administration (FAA) Deputy...more

Jones Day

Product Regulation and Metrology Bill Receives Royal Assent

Jones Day on

The Product Regulation and Metrology Act 2025 reforms the UK's post-Brexit product safety, metrology, and consumer protection frameworks....more

DLA Piper

Industrials Regulatory News and Trends - July 2025 #2

DLA Piper on

Welcome to Industrials Regulatory News and Trends. In this regular bulletin, DLA Piper lawyers provide concise updates on key developments in the industrials sector to help you navigate the ever-changing business, legal, and...more

Morrison & Foerster LLP

FDA Targets 52 “Obsolete” Food Standards of Identity for Revocation

On July 17, 2025, FDA announced several rulemakings aimed at modernizing its standards of identity (SOIs) for food products – regulations that define what a food must contain and how it must be made to lawfully bear a...more

Eversheds Sutherland (US) LLP

Global Supply Chain Horizons - July 2025

Welcome to the latest edition of our quarterly global supply chain horizons providing you with a update on the key developments from around the world. Cross-Border - China and the US trade deal - On June 27, the PRC...more

Akin Gump Strauss Hauer & Feld LLP

Regulatory Relief for Certain Stationary Sources to Promote American Chemical Manufacturing Security (Trump EO Tracker)

Grants a two-year exemption from compliance with the EPA’s HON Rule for 25 specified chemical manufacturing facilities. Extends implementation of new hazardous air pollutant standards under Section 112 of the Clean Air Act,...more

Akin Gump Strauss Hauer & Feld LLP

Regulatory Relief for Certain Stationary Sources to Promote American Iron Ore Processing Security (Trump EO Tracker)

Grants a two-year exemption from the EPA’s Taconite Rule to seven iron ore processing facilities operated by U.S. Steel and Cleveland-Cliffs. Extends all compliance deadlines under the rule, maintaining pre-existing emissions...more

Barnea Jaffa Lande & Co.

Israel’s Import Reform: “What’s Good for Europe Is Good for Israel”

The “What’s Good for Europe Is Good for Israel” reform came into effect at the beginning of 2025, with considerable. This reform allows importers to import diverse products to Israel in a new standardization track, based on...more

Goldberg Segalla

Support is Split as Maine’s Governor Gives State’s Foundational Packaging EPR Law a Modern Makeover

Goldberg Segalla on

Extended Producer Responsibility Legislation, also known as EPR laws, is a policy-based approach that holds producers accountable for the entire lifecycle of their products, particularly for take-back, recycling, and final...more

Jones Day

The EU's Deforestation Regulation: Will There Be Further Changes?

Jones Day on

The EU's Deforestation Regulation (EUDR), designed to ensure that no products that contribute to deforestation are sold in, or exported from, the EU, continues to be criticized by EU Member States and major market players....more

Shook, Hardy & Bacon L.L.P.

Think Tank Argues for Closing GRAS Loophole

U.S. policymakers should consider reforms to close loopholes surrounding Generally Recognized as Safe (GRAS) substances, according to an issue brief from the America First Policy Institute. The report recommends against...more

Blake, Cassels & Graydon LLP

Proposed Amendments to Ontario’s Blue Box Regulation

On June 4, 2025, the Ontario Ministry of the Environment, Conservation and Parks (the Ministry) proposed several amendments to the Blue Box Regulation. These proposed changes come alongside proposed amendments to the Resource...more

Morrison & Foerster LLP

German Accessibility Act Comes into Force

Individuals with disabilities face numerous challenges when accessing digital services and products, encountering significant barriers in their daily lives. The German Accessibility Act (Barrierefreiheitsstärkungsgesetz,...more

Quarles & Brady LLP

Puerto Rico Repeals Special Authorization Requirement for Nonresident Manufacturers and Distributors

Quarles & Brady LLP on

In July 2022, the agency formerly known as the Puerto Rico Auxiliary Secretariat for Regulation and Accreditation of Health Facilities (SARAFS), now the Auxiliary Secretariat for the Regulation of Public Health (SARSP),...more

PilieroMazza PLLC

New Developments for SBA’s HUBZone Program

PilieroMazza PLLC on

The U.S. Small Business Administration’s (SBA) Historically Underutilized Business Zone (HUBZone) program underwent a major rule change in January 2025, as we wrote about here. In this blog, PilieroMazza examines new...more

Wiley Rein LLP

ATF Allows Importation of Dual-Use Firearm Barrels, Irrespective of Previous Status or Configuration

Wiley Rein LLP on

The Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) has issued Ruling 2025-1, which loosens ATF’s policy with respect to the importation of firearm barrels. Specifically, the agency will now allow the importation of...more

131 Results
 / 
View per page
Page: of 6

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide