News & Analysis as of

Inspections Investigations

Goodwin

Common FDA Bioresearch Monitoring (BIMO) Violations: Updates from FY 2023 to Now

Goodwin on

The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits in order to effectively monitor the compliance of all FDA-regulated research....more

Akin Gump Strauss Hauer & Feld LLP

FDA Serves Up More Food for Thought: 2024 Will Be a Pivotal Year for the Agency’s Reorganization Efforts

In January, the U.S. Food and Drug Administration (FDA) kicked off the year by announcing a much-anticipated proposal to restructure their human foods program (HFP), and the agency has continued to work on the details of...more

Epiq

[Webinar] Competition and regulatory scrutiny in ‘the new normal’ - September 21st, 4:00 pm - 5:00 pm BST

Epiq on

As the Covid-19 pandemic subsides, there is mounting evidence of a shift in approach by regulatory enforcement agencies around the world. Industries that have historically been at lower risk of investigation are coming under...more

Woods Rogers

Virginia’s COVID-19 Enforcement Efforts: An Inside Look

Woods Rogers on

At the Virginia Bar Association’s Labor and Employment Conference, we heard first-hand from Jay Withrow, Esq., the Director of Legal Support for the Virginia Department and Labor and Industry’s Virginia Occupational Health...more

Oberheiden P.C.

FDA Inspection Audit? What to Expect

Oberheiden P.C. on

The Food and Drug Administration is the federal agency charged with ensuring the safety of food, medication and other consumable products. In carrying out its duties, the FDA conducts both inspections of plants and...more

McDermott Will & Emery

CMS Restarts Hospital Survey Activities Delayed by COVID-19

McDermott Will & Emery on

The Centers for Medicare and Medicaid Services (CMS) notified state survey agency directors that it has lifted previously imposed hospital survey suspensions and resumed routine hospital reaccreditation and recertification...more

K&L Gates LLP

Chancery Court Reaffirms Delaware Policy of Broad Section 220 Stockholder Inspection Rights

K&L Gates LLP on

In Lebanon County Employees’ Retirement Fund and Teamsters Local 443 Health Services & Insurance Plan v. AmerisourceBergen Corp., C.A. No 2019-0527-JTL (Del. Ch. Jan. 13, 2020), the Delaware Court of Chancery (the “Court”)...more

Epstein Becker & Green

#WorkforceWednesday: Office Building Guidance, OSHA Steps Up, “Fluctuating Workweek” Rule - Employment Law This Week®

It's #WorkforceWednesday. Here’s the week’s top workforce management and employment law news: CDC Issues Office Building Reopening Guidance The Centers for Disease Control has issued guidance for employers reopening office...more

Fisher Phillips

8 For ‘18: 8 Things for Employers to Look For from OSHA and MSHA in 2018

Fisher Phillips on

It’s that time of year again: for employers to celebrate the successes of the prior year and make plans and resolutions for the new one. But OSHA and MSHA are making New Year’s resolutions, too, and employers are well-advised...more

Stoel Rives LLP

Litigating Against Government Agencies: Case Studies in Challenges to Agency Decisions Under Federal Environmental Statutes

Stoel Rives LLP on

Record review challenges to federal agency decisions in the environmental context are, arguably, among the most frequently litigated and, yet, the least frequently won or favorably settled federal cases. Several case studies...more

The Volkov Law Group

Broker-Dealers: Pay Attention To Government Audits And Examinations

The Volkov Law Group on

The story of “The Boy Who Cried Wolf” applies with full force to the securities industry and the FCPA. ...more

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

Escalating Enforcement By MSHA Of Prohibition Against Advance Notice Of Inspection

Section 103 of the Federal Mine Safety Act requires the Secretary of Labor to conduct frequent inspections and investigations at mines....more

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