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New Guidance › Reporting Requirements › Manufacturers

Robinson+Cole Health Law Diagnosis

HHS Publishes 340B Guidance Proposing Rebate Pilot Program

Robinson+Cole Health Law Diagnosis on

On July 31, 2025, the Department of Health and Human Services (HHS) announced a much-anticipated 340B Rebate Model Pilot Program (Pilot Program) via guidance (Guidance) that will be formally published on August 1, 2025. The...more

MG+M The Law Firm

EPA Extends TSCA Section 8(d) Reporting Deadlines for Chemical Data Submissions

MG+M The Law Firm on

The US Environmental Protection Agency (EPA) has announced plans to extend the reporting deadlines for a rule under Section 8(d) of the Toxic Substances Control Act (TSCA). This rule mandates that manufacturers and importers...more

Morrison & Foerster LLP

New Dietary Ingredient Notifications: FDA Addresses Common Pitfalls and Shares New Educational Tools

Morrison & Foerster LLP on

On June 11, 2025, the U.S. Food and Drug Administration (FDA) released educational videos and a new fact sheet to facilitate compliance with the agency’s New Dietary Ingredient Notification (NDIN) review process. Under the...more

Hogan Lovells

Be vigilant: new post-market surveillance requirements for medical devices in Great Britain take effect

Hogan Lovells on

The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (PMSR), which were passed into law on 22 October 2024, came into force today (16 June 2025), amending the UK’s Medical...more

BakerHostetler

FDA Issues Draft Guidance on Replacing Color Additives in Drug Products

BakerHostetler on

On May 27, 2025, the Food and Drug Administration (FDA) released a new draft guidance, “Replacing Color Additives in Approved or Marketed Drug Products” (Guidance), that outlines regulatory expectations for manufacturers and...more

Robinson+Cole Manufacturing Law Blog

Filing EEO-1 Reports in 2025: Key Points Employers Need to Know

Robinson+Cole Manufacturing Law Blog on

Every year, private sector employers with 100 or more employees, and federal contractors with 50 or more employees who met certain criteria, are required to submit workforce demographic data to the federal Equal Employment...more

Wiley Rein LLP

EPA Announces Major Actions on PFAS and the TSCA New Chemical Program

Wiley Rein LLP on

The U.S. Environmental Protection Agency (EPA) has published a much anticipated roadmap for how Administrator Lee Zeldin plans to address per- and polyfluorinated substances (PFAS) in the coming months. The announcement...more

Bergeson & Campbell, P.C.

EPA Provides Technical Support for Companies Submitting New Chemical Data

Bergeson & Campbell, P.C. on

On April 25, 2025, the U.S. Environmental Protection Agency (EPA) announced the availability of new resources intended to help companies with the requirements described in EPA’s December 2024 final rule governing the review...more

Alston & Bird

FDA Publishes Guidance on Medical Device Shortages During Public Health Emergencies

Alston & Bird on

Our FDA/Food, Drug & Device and Health Care teams discuss new guidance from the Food and Drug Administration (FDA) on federal notification requirements for medical device manufacturing shortages during public health...more

Robinson+Cole Environmental Law +

PFAS Reporting Rules to Ring in the New Year

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As we have previously reported, PFAS (per- and polyfluoroalkyl substances) are a class of substances coming under increasing regulatory scrutiny.  As manufacturers ring in the new year they should be aware of two new PFAS...more

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