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Manufacturers Government Accountability Office

Mintz - Health Care Viewpoints

Looking Back and Moving Forward: MoCRA Regulatory Developments Ring in the New Year

A year has passed since Congress enacted the Modernization of Cosmetics Regulation Act (MoCRA) and enhanced the Food and Drug Administration’s (FDA) authority to regulate the cosmetics industry. Although MoCRA implementation...more

Ankura

Summary: The Government Accountability Office's Report on Medicare Part D Rebates

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On September 5, 2023, the United States Government Accountability Office (GAO) published its report titled Medicare Part D: CMS Should Monitor Effects of Rebates on Plan Formularies and Beneficiary Spending.The report...more

Jenner & Block

Government Contracts Legal Round-Up | September 2023 Issue 18

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Welcome to Jenner & Block’s Government Contracts Legal Round‑Up, a biweekly update on important government contracts developments. This update offers brief summaries of key developments for government contracts legal,...more

Bass, Berry & Sims PLC

Bid Protest Win for AM General on Multi-Billion Dollar Contract

Bass, Berry & Sims PLC on

We represented AM General (AMG), an automotive manufacturer that builds military vehicles for government customers, including the Humvee, in a successful bid protest involving a $9.7 billion contract for the U.S. Army to...more

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

GAO Encourages OSHA to Take Action in Meat and Poultry Industry

Recently, the United States General Accounting Office (GAO), which is a nonpartisan agency in the legislative branch, took on oversight of the executive branch agency, Occupational Safety and Health Administration (OSHA). In...more

Akin Gump Strauss Hauer & Feld LLP

FDA Changes Direction in Final CDS Guidance

FDA Also Issues Report on Software Pre-Cert Pilot, Leaving Unanswered Questions on Future of Software Regulation - Key Points - The Final Guidance does not address the FDA’s risk-based enforcement discretion policy...more

Foley & Lardner LLP

What Does “Manufacturing” Mean to You? The U.S. Government Wants to Know

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You probably know that the Buy American Act (BAA) establishes a preference, in procurements by U.S. government agencies, for the purchase of items manufactured in the United States. But did you know that the BAA contract...more

Morgan Lewis

After a Series of False Starts, FDA Resumes Domestic Inspections

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FDA announced on February 2 that it would be resuming domestic surveillance inspections across all product types, beginning on February 7, in light of declining COVID-19 rates. This announcement follows a series of inspection...more

Foley & Lardner LLP

Senate HELP Committee’s PREVENT Pandemics Act Draft Released: What to Know

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Following nearly a year of committee hearings, research, policy briefs, and discussion with agency experts, the Senate Health, Education, Labor, and Pensions (HELP) Committee Chairwoman Patty Murray (D-WA) and Ranking Member...more

Alston & Bird

FDA Issues New Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities

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Our FDA Compliance & Enforcement Team examines the Food and Drug Administration’s first guidance on remote interactive evaluations, a tool in response to the agency’s COVID-19 inspection postponements....more

Sheppard Mullin Richter & Hampton LLP

Breaking Down FDA’s New Remote Monitoring Strategy

On Wednesday, April 14, 2021, the US Food and Drug Administration (FDA) published a long-awaited final guidance document explaining its policy for conducting remote “evaluations” during COVID-19. According to the guidance,...more

Alston & Bird

COVID-19 Medical Products Supply Chain Week in Review – March 2021 #2

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In the past week, Johnson & Johnson and Merck agreed to cooperate on production of the Janssen vaccine, and the Biden Administration used the Defense Production Act (DPA) to facilitate the arrangement. In addition, the GAO...more

Bradley Arant Boult Cummings LLP

GAO Clarifies the Scope of Its Jurisdiction over OTA Protests

The Government Accountability Office (GAO), in Spartan Medical, Inc., B-419503, recently clarified the scope of its jurisdiction over bid protests involving an agency’s use of its other transaction agreement (OTA) authority....more

Foley Hoag LLP - Medicaid and the Law

The 340B Contract Pharmacy Saga

We are back again with another 340B post. The 340B program has recently been a regular feature on the blog in the context of ongoing litigation discussed here and here. Today, we wanted to provide readers the details of an...more

Sheppard Mullin Richter & Hampton LLP

Resurrecting the Spare Parts Bogeyman – A Refresher on Why the Government Gets It Wrong

The April issue of National Defense Magazine brought a well-written article by Susan Cassidy and her colleagues at Covington & Burling LLP on a recent DOD IG report analyzing (and criticizing) spare aviation parts pricing,...more

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

The Federal Role in the Toxic PFAS Chemical Crisis: U.S. Senate Homeland Security and Governmental Affairs Committee Hearing

The United States Senate Homeland Security and Governmental Affairs Subcommittee (“Subcommittee”) held a September 26th hearing titled: The Federal Role in the Toxic PFAS Chemical Crisis...more

Mintz - Health Care Viewpoints

Last Week in 340B: the Revival [not] of the 340B Mega-Guidance, Another Senate Hearing, and the Trump Blueprint to Lower Drug...

On Wednesday May 9th, I was floored when the Administration released the Spring 2018 Unified Agenda of Regulatory and Deregulatory Actions, which contained this nugget: by December 2018, HRSA will publish its 340B Omnibus...more

Holland & Knight LLP

White House Unveils Proposal on Drug Pricing

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On Feb. 9, 2018, the Trump Administration released a 30-page report analyzing domestic and global factors influencing drug pricing. The report by the Council of Economic Advisers (CEA) is expected to inform the HHS' Fiscal...more

Alston & Bird

A&B Healthcare Week in Review

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On January 9, 2017, the Food and Drug Administration (FDA) issued a draft guidance entitled, Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers; Draft...more

Robinson+Cole Manufacturing Law Blog

How The Failure To Comply With The Conflict Minerals Law Can Expose Manufacturers To Criminal Penalties

Last year, we provided an overview regarding the requirement that U.S. publicly traded companies disclose their use of “conflict minerals.”  As of 2014, the Government Accounting Office reported that 1,321 companies filed the...more

Mintz

Applying for a Waiver From U.S. Manufacturing Requirements For Federally Funded Intellectual Property

Mintz on

Countless ideas and inventions are developed at U.S. universities every year, often with federal funding. Many of these important ideas could not be commercialized for the public’s benefit without the Bayh-Dole Act, which...more

King & Spalding

Trade & Manufacturing Alert - August 2013

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In This Issue: - American Manufacturers See Increase In Orders - Ways And Means Conducts Hearing On Trade With Brazil - GAO Publishes Study On Counterfeit And Pirated Goods - News Of Note: ..China Issues...more

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