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King & Spalding

FDA Issues Two Guidances For the Device Q-Sub Process

King & Spalding on

CDRH and CBER Release Final Guidance for the Q-Submission Program and Draft Guidance for PreSTAR - On May 29, 2025, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Center...more

Schwabe, Williamson & Wyatt PC

NEPA’s Future Comes Into View with New Guidance and Rule Recission ‎

Schwabe, Williamson & Wyatt PC on

The past few months have been a period of high uncertainty over implementation of the National Environmental Policy Act (NEPA). In December, the Supreme Court heard arguments in a case that addressed the scope of foreseeable...more

Sheppard Mullin Richter & Hampton LLP

CFPB Opens Public Probe on Closing Fees

Sheppard Mullin Richter & Hampton LLP on

On May 30, the CFPB announced that it was probing mortgage closing costs as part of its continued focus on so-called junk fees. The Bureau’s request for information seeks input from the public on “the impact closing costs...more

Davis Wright Tremaine LLP

Broker Dealer Regulatory Digest - October 2023 - 2

Davis Wright Tremaine LLP on

The following newsletter provides a roundup summarizing enforcement actions, guidance, rulemakings, and other public statements taken by a federal and/or state financial services regulatory agency, specifically focusing on:...more

Stinson - Corporate & Securities Law Blog

FASB Proposes to Delay Effective Dates for Private and Certain Public Companies

Stinson - Corporate & Securities Law Blog on

The Financial Accounting Standards Board issued a proposed Accounting Standards Update, or ASU, that would grant private companies, not-for-profit organizations, and SEC registrants classified as smaller reporting companies...more

Cozen O'Connor

Don’t Say That! … Or Do? New Court Guidance on Employer Statements in Union Organizing Campaigns

Cozen O'Connor on

I often advise employers large and small on what to do (and what not to do) during union organizing campaigns. I am continually surprised at how many employers have misconceptions about the do’s and don’ts when a campaign is...more

Hogan Lovells

FDA Doubles Down on MUsT Studies for Sunscreens and Issues Final Guidance on Absorption Studies that Will Likely Be Needed for...

Hogan Lovells on

On May 10, 2019, FDA published a notice of availability for a final guidance document on Maximal Usage Trials (MUsT studies) for topically applied active ingredients being considered for OTC drug monographs, including...more

Hogan Lovells

FDA Announces Produce Safety Rule Enforcement Discretion Policy for Almonds, Pulse Crops, Wine Grapes, and Hops under FSMA

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) has issued Guidance detailing its intent to exercise enforcement discretion for the requirements of the Produce Safety rule as they apply to entities growing, harvesting, packing,...more

Hogan Lovells

Four new FDA guidances and proposed rule advance biosimilars policy framework

Hogan Lovells on

Yesterday, FDA released a series of guidances that aim to advance the agency’s biosimilars policy framework, along with a proposed rule on the definition of a “biological product,” which incorporates changes made by the...more

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