News & Analysis as of

The United States Food and Drug Administration

The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the... more +
The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the passage of the 1906 Pure Food and Drugs Act. The agency is charged with protecting the integrity of the nation's food supply and cosmetic products, as well as monitoring the safety and efficacy of drugs, medical devices, and biological products.  less -

Biosimilar Market Developments Continue Apace in 2018

It has been a few months since we reported on Federal Court wranglings with the Biologics Price Competition and Innovation Act, or BPCIA, which created the nation’s abbreviated marketing pathway for biosimilar products....more

FDA Accepts Sandoz aBLA for Adalimumab Biosimilar

by Goodwin on

Sandoz, a division of Novartis, announced on Tuesday that the FDA has accepted for review its BLA under the 351(k) pathway for a biosimilar candidate to AbbVie’s Humira (adalimumab). According to the press release, adalimumab...more

New Rules for Cannabis: The Coming Wave of California False Advertising and Unfair Competition Claims

by Wilson Elser on

The cannabis industry in California should expect to see a sharp increase in false advertising and unfair competition claims in 2018. These claims will be premised on violation of the state cannabis regulations, but will be...more

Homeopathic Regulation Has Come to Stay

by Arnall Golden Gregory LLP on

FDA closed out 2017 with a brief, but long-awaited, draft guidance on Drug Products Labeled as Homeopathic (Homeopathic Guidance), which lays out FDA’s new regulatory strategy for these products. Under the Federal Food, Drug,...more

Don’t Forget Your FDA Valentine

by Arnall Golden Gregory LLP on

In addition to reauthorizing various user fee programs, the FDA Reauthorization Act of 2017 (FDARA), which was enacted last summer, added a one-time marketing status reporting requirement for holders of new drug applications...more

Trump Administration: 2017 Recap and 2018 Outlook

On January 20, 2017, businessman Donald J. Trump was sworn in as the 45th President of the United States following a contentious and unconventional 2016 presidential election. Republicans also successfully maintained control...more

FDA Announces Release of 2018 Strategic Policy Roadmap

by Goodwin on

On January 11, FDA announced the release of its 2018 Strategic Policy Roadmap, which provides an overview of several policy areas that FDA intends to focus on in 2018. FDA noted that, among these policy areas, it planned to...more

Post-market medical devices, cybersecurity, and the U.S. FDA’s growing concerns

by Hogan Lovells on

From insulin pumps and pacemakers to defibrillators, medical devices increasingly rely on wireless and internet connectivity for efficient operations. Unfortunately, these interconnections also leave devices vulnerable to an...more

Capitol Hill Healthcare Update

by BakerHostetler on

House Republicans will gather tonight for a GOP-only meeting to plot strategy on passing a stopgap budget bill, but a breakdown among key senators on separate immigration legislation has elevated the risk of a government...more

FDA Releases 2018 Roadmap: Focus On Digital Health Continues

by Kelley Drye & Warren LLP on

Last week, FDA released a document outlining its policy priorities for the coming year. “Healthy Innovation, Safer Families: FDA’s 2018 Strategic Roadmap” addresses continued focus on digital health, among other priorities,...more

Food, Dietary Supplement & Cosmetics Update | Vol. V, Issue 1

by Jones Day on

Top News - FDA Announces Intention to Not Enforce Certain FSMA Final Rules Provisions - On January 4, 2018, the U.S. Food and Drug Administration ("FDA") issued a guidance announcing that it does not intend to enforce...more

3D Printing Meets Medical Devices: FDA Weighs In On Additive Manufacturing

In December, the U.S. Food and Drug Administration (FDA) issued guidance on Technical Considerations for Additive Manufactured Medical Devices. The guidance represents FDA’s efforts to provide regulatory direction about...more

FDA Proposes to Delay Off-Label “Intended Use” Rule

by Reed Smith on

Perhaps you have heard that elections have consequences. That is true not only for high-profile issues that hog the headlines on CNN and Fox News, but it is also true for drug and device litigation regulation. Such drug and...more

FDA Presents Webinar on Technical Considerations for Additive Manufactured Medical Devices

by Reed Smith on

On December 5, 2017, the U.S. Food and Drug Administration (FDA) released the final version of its guidance entitled “Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug...more

Wrap-Up of Federal and State Chemical Regulatory Developments, January 2018

by Bergeson & Campbell, P.C. on

TSCA/FIFRA/TRI - Lynn L. Bergeson, “Resetting The TSCA Inventory: Why This Is Important,” Environmental Quality Management, Volume 27, Issue 1, Fall 2017: On August 11, 2017, the U.S. Environmental Protection Agency (EPA)...more

Food and Beverage News and Trends

by DLA Piper on

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. Inspector general criticizes FDA food recall procedures - On December 26,...more

Food & Beverage Litigation Update | January 2018

FDA Announces Intent Not to Enforce Portions of FSMA - The U.S. Food and Drug Administration (FDA) has announced it will not enforce certain provisions of the Food Safety Modernization Act (FSMA) because the agency needs...more

Alston & Bird Healthcare Week in Review

by Alston & Bird on

On January 8, 2018, the Department of Veterans Affairs (VA) issued a rule entitled, Reimbursement for Emergency Treatment. The VA revised its regulations concerning payment or reimbursement for emergency treatment for...more

In 2018 Strategic Policy Roadmap, FDA Unveils Plans for 2018 Addiction, Drug Competition and Innovation Efforts

by Faegre Baker Daniels on

On January 11, 2018, the Food and Drug Administration (FDA) released its 2018 Strategic Policy Roadmap, which sheds light on the agency’s key focus areas for the year. This Roadmap builds on some of the FDA’s existing work,...more

FDA 2017 Year in Review

by McDermott Will & Emery on

The US Food and Drug Administration’s (FDA’s) 2017 regulatory agenda was marked by inactivity in the months following the presidential inauguration. Since FDA Commissioner Scott Gottlieb’s Senate confirmation in May 2017, the...more

FDA to step up enforcement of homeopathic medicine

by Thompson Coburn LLP on

Homeopathic medicine has long occupied a niche in American culture. Since 1988, with the issuance of the Compliance Policy Guide, § 400.400, “Conditions Under Which Homeopathic Drugs May be Marketed,” the FDA has had a...more

Big Brother is a Pill: Digital Tracking Drugs

by McGuireWoods LLP on

Drug adherence programs have significantly evolved over the last few years with drug companies, health plans, and providers taking steps to monitor patient medication compliance. Drug adherence is the degree to which a...more

The Life Sciences Report - Winter 2018

Life Beyond FDA Clearance or Approval: The Reimbursement Challenge - To medical device manufacturers, winning premarket approval or 510(k) clearance from the U.S. Food and Drug Administration (FDA) is only half the battle....more

Get by with a Little Help from My Friends (Maybe Not): FDA Reiterates Reliance on Others Doesn’t Ensure Regulatory Compliance

by Arnall Golden Gregory LLP on

Here we go again. The Food and Drug Administration issued a Warning Letter on December 13, 2017, to a Korean pharmaceutical company for non-compliance with current Good Manufacturing Practice requirements. What caught our eye...more

State Law Cannot Circumvent Congress’s Scheme for Biologics

In Amgen v. Sandoz, No. 2015-1499, the Federal Circuit affirmed the Northern District of California’s decision that Sandoz had not waived its preemption defense and that the Biologics Price Competition and Innovation Act of...more

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