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Deadlines Food and Drug Administration (FDA)

Harris Beach Murtha PLLC

GLP-1 Weight-Loss Drugs Off Shortage List; Deadlines to Stop Compounding

Glucagon-like peptide-1 agonists, a class of medications known as GLP-1s, have grown in popularity, initially for the treatment of type 2 diabetes and more recently for obesity and other labeled and off-label indications for...more

DLA Piper

Certain DSCSA Deadline Extensions Set to Eclipse in 2025

DLA Piper on

The Drug Supply Chain Security Act (DSCSA) (section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 USC §360eee – 1) was introduced in response to several drug contamination, counterfeiting, and diversion...more

McDermott+

Healthcare Preview for the Week of: December 2, 2024

McDermott+ on

Watchful Waiting: Three Weeks Left in Lame Duck - Congress returns on Tuesday to begin the remaining three weeks of the lame duck session. Lawmakers have a packed agenda, and they have 18 days to pass a bill funding the...more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, Issue 7, November 2024

Welcome to our seventh issue of The Health Record - our healthcare law insights e-newsletter. This will be our final issue of 2024. When we started this publication earlier this year, our goal was to provide our clients,...more

Cozen O'Connor

[Event] Health Care & Life Sciences 2025 - December 5th, Philadelphia, PA

Cozen O'Connor on

Cozen O'Connor will host Health Care & Life Sciences 2025, our annual in-person seminar exploring critical issues impacting health care and life sciences businesses. Join attorneys and professionals from our Health Care &...more

ArentFox Schiff

Four Months Out: Private Fund Advisors Prepare for September Compliance Deadline Amidst Challenge in the Fifth Circuit

ArentFox Schiff on

In September 2023, we covered the Rules (Rule) published by the US Securities and Exchange Commission (SEC), developed to promote transparency for investors by increasing visibility into compensation schemes, sales practices,...more

Butler Snow LLP

Rule 104(c)(3): When Justice So Requires

Butler Snow LLP on

The following is an article of fiction. The author simply has a well-developed imagination. He should have won summary judgment. And he had – on all claims save one. But one was enough. And now he found himself in...more

ArentFox Schiff

FDA Delays Enforcement of Cosmetic Facility Registration and Product Listing Requirements

ArentFox Schiff on

On November 8, the US Food and Drug Administration (FDA) announced its intent to delay enforcement of the requirements for cosmetic product facility registration and cosmetic product listing. On November 8, the US Food and...more

McDermott Will & Schulte

FDA Publishes Proposed Rule on National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics...

The US Food and Drug Administration (FDA) published its proposed rule National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers on February 4, 2022. The proposed rule sets...more

Oberheiden P.C.

FDA Warning Letter Response Strategies (Step-By-Step)

Oberheiden P.C. on

FDA Warning letters can be harbinger of formal civil and criminal investigations. If your business receives such a notice of non-compliance from the FDA, you should immediately contact an experienced FDA defense attorney....more

Arnall Golden Gregory LLP

Are You Ready for OTC Drug Reform? The 180 Day Deadline is Fast-Approaching

The Coronavirus Aid, Relief and Economic Security Act (the CARES Act) ushered in a wave of reforms to the Food and Drug Administration’s regulation of over-the-counter (OTC) drugs in the United States.  We previously...more

Mintz - Health Care Viewpoints

Further Update on FDA’s Comprehensive Regenerative Medicine Framework: November 2020 Deadline Extended by Six Months

About a month ago, I predicted on this blog that Food and Drug Administration’s November 2020 enforcement discretion deadline announced as part of its Comprehensive Regenerative Medicine Policy Framework would most likely not...more

Hogan Lovells

Coronavirus: The Hill and the Headlines – COVID-19 D.C. Update – July 2020 #1

Hogan Lovells on

In Washington: Senate Republicans are beginning to put together their own fifth COVID-19 aid package, but with no apparent Democratic involvement it’s unlikely to receive enough support to pass both chambers, according to...more

Miller & Martin PLLC

FDA Extends Deadline to Submit Public Comment for Cannabis Products

Miller & Martin PLLC on

In its April 3, 2018 Federal Register Notice, the Food and Drug Administration (“FDA”)  announced its May 31, 2019 public hearing for the scientific data and information about products containing cannabis and cannabis derived...more

Holland & Knight LLP

FDA Guidance on DSCSA Product Identifier Requirements

Holland & Knight LLP on

Members of the pharmaceutical supply chain, including drug wholesalers and manufacturers, are grappling with fast-approaching deadlines for compliance with new federal regulatory requirements. The Drug Quality and Security...more

Perkins Coie

Industry Insight: FDA Extends Deadline for Eliminating PHOs

Perkins Coie on

The U.S. Food & Drug Administration determined in 2015 that Partially Hydrogenated Oils (“PHOs”) are not “Generally Recognized as Safe,” or GRAS. PHOs are the leading source of trans fats in the human diet. In the nutrition...more

McDermott Will & Schulte

FDA Extends Unique Device Identification (UDI) System Compliance Deadlines for Certain Low-Risk Medical Devices

In Depth - On June 2, 2017, the US Food and Drug Administration (FDA) announced that it plans to delay the dates by which certain Class I devices and unclassified devices must comply with the agency’s unique device...more

Kelley Drye & Warren LLP

FDA Extends Menu Labeling Deadline

Responding to input from stakeholders, the FDA has decided to extend the deadline for complying with its Menu Labeling Final Rule from December 1, 2015 to December 1, 2016. In general, the Rule requires chain restaurants and...more

Snell & Wilmer

Newest Food Safety Rules Approach Deadline

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In June, a federal judge in California ordered the U.S. Food and Drug Administration (“FDA”) to issue proposed rules for the Food Safety Modernization Act (“FSMA”) by November 30, 2013. In July, the agency requested an...more

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