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Supply Chain Food and Drug Administration (FDA) Public Health

Foley Hoag LLP

FDA Launches PreCheck Program to Accelerate Onshoring of Drug Manufacturing Facilities

Foley Hoag LLP on

Key Takeaways: - The FDA PreCheck program, launched in response to Executive Order 14293, is designed to streamline and expedite the construction and approval of domestic drug manufacturing facilities, aiming to reduce...more

Carlton Fields

Agency Actions, Trade Deals, and Other Initiatives to Further Executive Order Goals for the Pharma Industry

Carlton Fields on

The Trump administration has issued numerous pharma-focused executive orders, including “Lowering Drug Prices by Once Again Putting Americans First,” “Regulatory Relief to Promote Domestic Production of Critical Medicines,”...more

BakerHostetler

[Podcast] FDA-Regulated Products Supply Chain Disruptions: Industry Perspective

BakerHostetler on

Supply chain disruptions have become a significant challenge for the U.S. FDA-regulated products industry, affecting the availability of pharmaceuticals, medical devices, and food. These disruptions are caused by various...more

DLA Piper

Food and Beverage News and Trends - May 2025 #2

DLA Piper on

FDA approves three color additives derived from natural sources. In order to “expand the palette of available colors from natural sources for manufacturers to safely use in food,” the FDA announced on May 9 that it has...more

Akin Gump Strauss Hauer & Feld LLP

HHS, FDA Announce Multiple Initiatives on Food Safety, Quality and Compliance Fronts

In the past week, the U.S. Food and Drug Administration (FDA), in collaboration with the Department of Health and Human Services (HHS) announced three new initiatives related to food safety and food supply chain transparency....more

Braumiller Law Group, PLLC

Hot Topics in International Trade - November 2023 - Any Comments on FDA’s New Proposed Rule on Prior Notice Regulations?

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 requires the Food and Drug Administration (FDA) to take additional measures for safeguarding the public against potential terrorist attacks on...more

Knobbe Martens

FDA Updates Medical Device Shortages List

Knobbe Martens on

The FDA has updated its Medical Device Shortages List to remove Specimen Collection, Laboratory Reagents and Testing Supplies, Transport Media Device, Saline Vascular Access Flush, and Certain Ventilation-Related Products....more

Dorsey & Whitney LLP

HHS and FDA Take Additional Measures to Aid Post-PHE Transition for Pharmacy Providers

Dorsey & Whitney LLP on

For the last three years, the federal government has taken considerable steps to aid providers in the fight against COVID-19. Although many of the waivers and flexibilities initiated in response to the pandemic have since...more

McDermott Will & Schulte

Special Report - 2022 FDA Year in Review

As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more

Clark Hill PLC

Window on Washington – Vol. 6, Issue 32

Clark Hill PLC on

Outlook for This Week in the Nation’s Capital - Congress. The House and Senate are both in recess until Labor Day. Once they return, they will have a packed to-do list ahead of the November elections, which may include...more

MoFo Life Sciences

FDA Releases Draft Guidance On Digital Health Technologies For Remote Data Acquisition In Clinical Investigations

MoFo Life Sciences on

In response to COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) continues to work in support of clinical investigation sponsors and an evolving environment in which they run their clinical trials while...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

Arnall Golden Gregory LLP

Tell Me, I’ve Got to Know: FDA Issues Draft Guidance on 506J Notifications for Medical Devices

Bob Dylan sang, “Tell Me, I’ve Got to Know.” In January 2022, the Food and Drug Administration said the same to the medical device industry when it issued a draft guidance, “Notifying the FDA of a Permanent Discontinuance or...more

Hogan Lovells

[Webinar] Looking ahead to 2021: Impacts of the election for the life sciences and health care industry - November 19th, 12:30 pm...

Hogan Lovells on

Life Sciences and Health Care Horizons virtual event series - The fast pace of innovation in the life sciences and health care industry has reached an all-time high in 2020 as the industry grapples with the new reality of...more

Akin Gump Strauss Hauer & Feld LLP

Executive Order on Essential Medicines: A Timeline and Overview of Key Provisions

On August 6, President Trump issued an Executive Order (EO) titled “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States.” The far-reaching EO seeks to ensure the domestic...more

Hogan Lovells

Coronavirus: The Hill and the Headlines – COVID-19 D.C. Update – July 2020 #15

Hogan Lovells on

In Washington - FEMA administrator Peter Gaynor cautiously told the House Homeland Security Committee yesterday that personal protective equipment (PPE) distribution in the U.S. is “healthy” but admitted that the agency...more

Akin Gump Strauss Hauer & Feld LLP

COVID-19 Policy Update #21

Leaders of Small Business Committee Reach Consensus on Bill to Extend PPP Loan Deadline, Senate Fails to Clear Measure by Unanimous Consent as Phase 4 Negotiations Likely to Dominate June - Bipartisan leaders of the Senate...more

Hogan Lovells

Belgium follows the FDA's approach on the reprocessing of surgical masks and FFP2/FFP3 facemasks

Hogan Lovells on

Given the challenges in maintaining the supplies of healthcare materials such as surgical masks and FFP2 and FFP3 face masks, the Belgian Task Force on shortages, a working group set up by the Belgian Federal Agency for...more

Goodwin

U.S. Cares Act Supply Shortage Provisions: What Drug And Device Manufacturers Need To Know

Goodwin on

On March 27, 2020, President Trump signed into law the Coronavirus Aid, Relief, and Economic Security (CARES) Act in response to the U.S. COVID-19 pandemic. Throughout the COVID-19 outbreak, there has been public discussion...more

Hogan Lovells

COVID-19 Update: FDA Announces Plans to Conduct Remote FSVP Inspections

Hogan Lovells on

In response to the COVID-19 outbreak, the U.S. Food and Drug Administration (FDA) has announced it will begin requesting that importers send the agency records required under the Foreign Supplier Verification Programs (FSVP)...more

Foley & Lardner LLP

Food Safety and the Coronavirus – Latest Updates from FDA

Foley & Lardner LLP on

The spread of COVID-19 has led to questions for the food industry regarding the food supply chain, FDA’s role in protecting it, and changes to FDA operational procedures during the public health emergency. In response, FDA...more

Hogan Lovells

The global impact of COVID-19 on clinical trials and countermeasure development

Hogan Lovells on

The World Health Organization (WHO) has determined that the 2019 novel coronavirus is a “global pandemic” and President Trump has declared a national emergency as the impact of the virus on all aspects of daily life continues...more

Morgan Lewis

Potential Impact of Coronavirus (COVID-19) on the Pharmaceutical and Biotech Industries

Morgan Lewis on

The pharmaceutical and biotech industries are assessing how the coronavirus (COVID-19) pandemic may impact business operations. Presently, most countries have confirmed cases of COVID-19 and thousands of people have had...more

McDermott Will & Schulte

FDA Update: COVID-19 Testing, Vaccine Development and Other Impacts

In response to the United States’ rapidly evolving public health situation, the US Food and Drug Administration (FDA) recently released guidance on high-complexity in vitro diagnostic (IVD) tests for COVID-19. This article...more

Morgan Lewis

Recent FDA Medical Device Developments in Response to COVID-19

Morgan Lewis on

The US Food and Drug Administration is working to facilitate emergency use authorization for coronavirus (COVID-19) medical devices, including diagnostic tests and respirators, while also working with the Federal Trade...more

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