News & Analysis as of

Federal Food Drug and Cosmetic Act (FFDCA) Coronavirus/COVID-19

Goodwin

FDA Platform Technology Draft Guidance Highlights Utility of Obscure Patent Term Extension Provision

Goodwin on

As discussed in a prior Goodwin Alert, the US Food and Drug Administration (FDA) recently released Draft Guidance for designating a platform technology for drug development pursuant to § 560k of the Federal Food, Drug, and...more

Alston & Bird

Health Care Week in Review: House Committee on Oversight and Accountability Held a Hearing on PBMs; HHS Reorganizes Technology,...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

Health Care Week in Review: House Held a Markup of 23 Bills; Senators Announced a Proposal on Primary Care Payment Reform

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

MoFo Life Sciences

Non-Lab Diagnostics: FDA Regulatory Considerations

MoFo Life Sciences on

The advent of the COVID-19 rapid antigen test launched at-home diagnostics to the forefront of conversation in the life sciences industry. Many believe this is only the beginning. As the share of telehealth services...more

Mintz - Health Care Viewpoints

The LDT Debate: Unpacking Public Responses to FDA’s Proposed Rule

The U.S. Food and Drug Administration (FDA) recently released a proposed rule that would seek to regulate laboratory developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). This rule...more

Husch Blackwell LLP

Legal Insights for Manufacturing: Outlook for 2024

Husch Blackwell LLP on

Our downloadable report, Legal Insights for Manufacturing, explores how the business, legal, and regulatory framework is evolving—and will evolve—to address the large generational shifts taking place. This year, our report...more

Jones Day

Industry Anticipates Impending FDA Proposed Regulation Addressing Laboratory Developed Tests

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Stakeholders prepare for the U.S. Food and Drug Administration's ("FDA") rulemaking effort to "make explicit" that laboratory developed tests ("LDTs") are devices subject to the agency's oversight, reigniting outstanding...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

Foley Hoag LLP

The FDA Finalizes Transition Plan for Medical Device Authorizations and Policies Affected by Covid-19 PHE

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The Food and Drug Administration (FDA) has announced transition plans for Emergency Use Authorization (EUA)-authorized medical devices and devices marketed pursuant to COVID-19-related guidance documents. The Transition...more

MoFo Life Sciences

Ending The COVID-19 Public Health Emergency – What Happens Next

MoFo Life Sciences on

The Biden administration announced on January 30, 2023, that it plans to terminate the COVID-19 public health emergency declaration (the “PHE declaration”) on May 11, 2023. COVID-19 EUA medical products and policies- As FDA...more

Alston & Bird

Public Health Emergency Set to End May 11, 2023: What It Means for FDA-Regulated Firms and Products

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The coming end to the COVID-19 public health emergency doesn’t mean the end of all FDA authorities exercised during the pandemic. Our FDA/Food, Drug & Device Team explores what will happen to the FDA’s emergency use...more

McDermott Will & Emery

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

ArentFox Schiff

Investigations Newsletter: Medical Device Company to Pay Over $700,000 To Resolve Criminal Allegations

ArentFox Schiff on

Medical Device Company to Pay Over $700,000 To Resolve Criminal Allegations - On January 4, 2023, a criminal information was filed in the Southern District of Illinois, in which Jet Medical Inc. (Jet), a medical device...more

Wiley Rein LLP

Be Prepared: FDA Signals Transition Countdown for Medical Devices Marketed Under COVID-Era Enforcement Policies, EUAs

Wiley Rein LLP on

On October 17, 2022, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released the list of guidance documents proposed for publication in fiscal year 2023. While it is unclear if...more

Mintz - Health Care Viewpoints

Regulatory Roundup: Important FDA Developments at the End of September 2022

There were so many interesting and significant developments related to the various missions of the U.S. Food and Drug Administration (FDA) during the last week or so of September 2022 that we decided to create a summary...more

Wiley Rein LLP

FDA’s Remote Regulatory Assessments Q&A Draft Guidance Document Explains the Regulated Industry’s New Virtual Reality

Wiley Rein LLP on

The U.S. Food and Drug Administration (FDA or Agency) recently announced the availability of a new draft guidance titled “Conducting Remote Regulatory Assessments: Questions and Answers” (RRA Draft Guidance). Remote...more

Foley & Lardner LLP

Snackable: Food & Beverage Review

Foley & Lardner LLP on

We invite you to enjoy a review of the food and beverage industry with bite size articles ranging from regulatory and real estate trends to litigation and M&A happenings. The past two years have seen significant changes...more

Mintz - Health Care Viewpoints

Summer 2022 Is Here – Do You Know How the FDA User Fee Legislation Is Going?

Anyone who has spent any time around health care policymaking circles in Washington, D.C. has heard about the intense five-year cycle Congress goes through in order to reauthorize the biggest user fee programs at the Food and...more

Mintz - Health Care Viewpoints

FDA Expresses Displeasure with Consumer Products Containing Trendy Cannabis Ingredient Delta-8 THC

On May 4, 2022, the U.S. Food and Drug Administration (FDA) for the first time issued warning letters related to products containing delta-8 tetrahydrocannabinol (delta-8 THC). FDA has previously sent warning letters to...more

King & Spalding

And So It Begins: House Energy and Commerce Leaders Unveil FDA User Fees Legislative Package

King & Spalding on

On May 4, 2022, House Energy and Commerce (“E&C”) Committee leaders unveiled the legislative package to reauthorize the U.S. Food and Drug Administration (“FDA” or the “Agency”) user fee agreements (the “House Draft”)...more

Bradley Arant Boult Cummings LLP

COVID and CBD Prove to be a Powder Keg for Federal Regulators

Cannabis operators (from marijuana to hemp-derived products such as CBD) often get the sense they are one of the central targets of the federal government’s reach. But they are not in the same league lately as the COVID-19...more

Farrell Fritz, P.C.

Herbal COVID Remedy Is Not The Government’s Cup of Tea

Farrell Fritz, P.C. on

Last week, the EDNY and the DOJ Consumer Protection Branch brought a civil enforcement action against defendants who manufacture and sell an herbal tea product called B4B Earth Tea Extra Strength (“Earth Tea”).  Earth Tea...more

Goodwin

Draft Senate Legislation Expands FDA’s QIDP Designation

Goodwin on

On Tuesday, January 25, Senate Health, Education, Labor, and Pensions (HELP) Committee Chair, Senator Patty Murray (D-WA), and Ranking Member, Senator Richard Burr (R-NC) released a discussion draft of the Prepare for and...more

Alston & Bird

Alston & Bird Health Care Week in Review - February 2022 #1

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

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