News & Analysis as of

New Guidance Public Health

Hogan Lovells

FDA Commissioner’s National Priority Voucher program comes with questions surrounding implementation

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) announced Tuesday a “Commissioner’s National Priority Voucher” (CNPV) program, which will provide a “limited number” of vouchers to sponsors of drug products that are “aligned with...more

Morgan Lewis - As Prescribed

Navigating FDA’s Evolving Approach to Guidance Publication for Medical Products

Guidance development and publication from the Food and Drug Administration (FDA) has long been considered an essential element of medical product development, approval, and regulation. While temporary pauses in guidance...more

Holland & Knight LLP

Hopefully EPA Will Soon Pass Judgment on New Technologies to Destroy PFAS

Holland & Knight LLP on

On April 28, 2025, the U.S. Environmental Protection Agency (EPA) announced "major EPA actions to combat PFAS contamination." EPA Administrator Lee Zeldin said that he has "long been concerned about PFAS and the efforts to...more

Holland & Knight LLP

New York State Department of Health Issues Long-Awaited Guidance on Material Transactions Law

Holland & Knight LLP on

The New York State Department of Health (DOH) has published a set of Frequently Asked Questions (FAQs) to provide guidance on the "Disclosure of Material Transactions" law that took effect on Aug. 1, 2023. Pursuant to Article...more

Gibney Anthony & Flaherty, LLP

USCIS Waives COVID-19 Vaccination for Adjustment of Status Applicants

Overview Effective January 22, 2025, USCIS will no longer require Adjustment of Status applicants to obtain a COVID-19 vaccination as part of the Adjustment of Status process. USCIS will waive all requirements that Adjustment...more

Akin Gump Strauss Hauer & Feld LLP

FDA Unveils Draft Guidance on Developing Drugs and Biological Products for Weight Reduction

On January 7, the FDA made available draft guidance on the development of drugs and biological products for weight reduction within the Center for Drug Evaluation and Research intended for reduction and long-term maintenance...more

DLA Piper

Industrials Regulatory News and Trends - December 2024 #2

DLA Piper on

California amends Prop 65 short-form warnings. California’s Office of Environmental Health Hazard Assessment has announced long-expected new amendments to its Prop 65 short-form warning requirements. ...more

Smith Anderson

Update on Regulatory Relief for North Carolina Long-Term Care Facilities After Hurricane Helene

Smith Anderson on

The North Carolina Division of Health Service Regulation (“DHSR”) has issued guidance to Adult Care Home (ACH), Family Care Home (FCH), and Skilled Nursing Facility (SNF) providers regarding temporary waivers or modification...more

Troutman Pepper Locke

New FDA Guidance on AI and Medical Products

Troutman Pepper Locke on

n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Lagoon Requirements/Best Management Practices for Use/Disposal of Sewage Sludge: U.S. Environmental Protection Agency Issues...

The United States Environmental Protection Agency (“EPA”) issued a February 2024 guidance document (“Guidance”) titled: Understanding Lagoon Requirements Under 40 C.F.R. Part 503: Best Management Practice for Use or...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

California Department of Public Health Issues New Order Revising COVID-19 Definitions and Procedures

On January 9, 2024, the California Department of Public Health (CDPH) issued an order addressing COVID-19 disease control and prevention. The new order is for non-healthcare settings, takes effect immediately, and is...more

Robinson+Cole Environmental Law +

PFAS Reporting Rules to Ring in the New Year

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

Foley Hoag LLP - Security, Privacy and the...

CISA Publishes Mitigation Guide to Combat Cyber Threats in the Healthcare and Public Health Sectors

If you need a little intellectual stimulation after hours of Thanksgiving turkey and football, the U.S. Cybersecurity and Infrastructure Security Agency (CISA) has just the thing — the new CISA Mitigation Guide for the...more

Ballard Spahr LLP

COVID-19 Coverage Without a Deductible Ends After 2024

Ballard Spahr LLP on

The Internal Revenue Service (IRS) has issued new guidance, Notice 2023-37, which states that for plan years ending after December 31, 2024, HSA-compatible high-deductible health plans (HDHPs) will no longer be permitted to...more

King & Spalding

FDA Releases Guidance on Testing High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol

King & Spalding on

On May 10, the U.S. Food and Drug Administration (“FDA”) released a new guidance document Guidance for Industry: Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution,...more

Goodwin

The Long (Un)Winding Road, Part 2: The FDA’s Final Transition Guidances for COVID-19 Devices

Goodwin on

In early 2023, the Biden administration announced and set into motion its plans to wind down a number of pandemic-related programs and allow the COVID-19 public health emergency (PHE) declaration, which has been in effect...more

Robinson+Cole Health Law Diagnosis

CMS Issues Guidance for Providers on Waivers, Flexibilities and End of COVID-19 Public Health Emergency

The Centers for Medicare & Medicaid Services (CMS) recently issued a Fact Sheet (Fact Sheet) providing guidance on the impact of the end of the federal COVID-19 Public Health Emergency (PHE) on certain regulatory waivers,...more

King & Spalding

EPA Releases a Cumulative Impacts Addendum to its Environmental Justice Tool Kit

King & Spalding on

On January 11, 2023, EPA’s Office of the General Counsel released a Cumulative Impacts Addendum (“Addendum”) to its May 2022 publication Legal Tools To Advance Environmental Justice, continuing to signal its focus on...more

Littler

Cal/OSHA ETS Provisions Remain Briefly in Effect Until OAL Approval Process for Non-Emergency Regulation is Complete

Littler on

The non-emergency COVID regulation adopted by the Cal/OSHA Standards Board at its meeting on December 15, 2022, will not become effective until approved by the Office of Administrative Law (OAL), which is expected to occur in...more

Burr & Forman

EPA Continues its Journey Down the PFAS Road(map)

Burr & Forman on

On December 5, 2022, the U.S. EPA issued a memorandum entitled, Addressing PFAS Discharges in NPDES Permits and Through the Pretreatment Program and Monitoring Programs. The memorandum “provides EPA’s guidance to states and...more

Littler

California Changes “Close Contact” Definition Under Cal/OSHA COVID Emergency Standard and Issues Revised Proposal for...

Littler on

On October 13, 2022, the California Department of Public Health (CDPH) issued an order effective October 14, 2022, updating the definition of close contact under the Third Revised COVID Emergency Temporary Standard and...more

Mintz - Health Care Viewpoints

FDA Is Accepting EUA Requests for Monkeypox Tests, But Time is of the Essence

The Food and Drug Administration (FDA) issued a guidance on development and emergency use authorization of diagnostic and serological tests for the monkeypox virus following the Secretary of the Department of Health and Human...more

Littler

New York State to Follow CDC Guidance on COVID-19 Quarantines and Isolations

Littler on

On September 14, 2022, the New York State Department of Health updated its COVID-19 quarantine and isolation webpage to remove earlier written COVID-19 guidance and tables dated May 31, 2022 (the “May Guidance”). The webpage...more

CDF Labor Law LLP

 CDC’s New Relaxed COVID-19 Guidelines & How They Affect the Workplace

CDF Labor Law LLP on

On August 11, 2022, the Center for Disease Control (“CDC”) updated and further loosened COVID-19 guidelines. A summary of the guidelines demonstrate the shift in the CDC’s focus to avoid transmitting severe illness, as...more

Stradling Yocca Carlson & Rauth

Keeping On Top of the Guidance: New CDC Guidance, Proposed Updates To Emergency Temporary Standards, And Continued Immigration...

While some of us may have thought COVID-19 would be temporary, we now know it is here to stay. Yesterday, the CDC released new guidance on what to do after being exposed to someone with COVID-19. Additionally, Cal/OSHA is...more

226 Results
 / 
View per page
Page: of 10

"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