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 -

FDA Commissioner Nominee Gottlieb Written Responses Signal Support for Food Safety and Science-Based Approach to Consumer...

by Kelley Drye & Warren LLP on

Dr. Scott Gottlieb, recently submitted written responses to questions posed by members of the Senate Health, Education, Labor and Pensions Committee as a follow up to his hearing on April 5. As a follow up to our April 13...more

Blog: User Fee Act Legislation Introduced Free of Controversial Issues…for the Time Being

by Cooley LLP on

Recently, the House Energy and Commerce Committee and Senate Health, Education, Labor and Pensions (HELP) Committee introduced a bipartisan discussion draft of legislation to reauthorize the Food and Drug Administration’s...more

Food and Beverage News and Trends - April 2017

by DLA Piper on

Six consumer groups ask major food companies to oppose regulatory reform bill. On April 11, a coalition of six consumer organizations sent a letter to 11 major food manufacturers, retailers and restaurant chains, calling upon...more

Analysis: Supreme Court Oral Argument in Sandoz v. Amgen

by Goodwin on

The transcript of the April 26 Supreme Court oral argument in Sandoz v. Amgen has been posted online. As we covered briefly, the questioning during today’s argument focused primarily on three points....more

Glenmark Pharmaceuticals Begins Clinical Investigation for Omalizumab Biosimilar

by Goodwin on

In a press release, Glenmark Pharmaceuticals announced today that the U.S. FDA has cleared Glenmark’s Investigational New Drug (IND) application of GBR 310, a proposed biosimilar of XOLAIR® (omalizumab), to initiate a...more

Reminder: Supreme Court Arguments on April 26th in Amgen v. Sandoz

by Goodwin on

As a reminder to our readers, tomorrow the Supreme Court will hear oral arguments in Amgen v. Sandoz regarding the following questions: ..Whether a biosimilar applicant is required by 42 U.S.C. § 262(l)(2)(A) to provide...more

Supreme Court Preview -- Sandoz Inc. v. Amgen Inc. -- 180 Day Notice of Commercial Marketing Provisions of BPCIA

On Wednesday, April 26, the Supreme Court will hear oral arguments in Sandoz Inc. v. Amgen Inc, involving interpretation for the first time of the Biologics Price Competition and Innovation Act ("BPCIA"), which was enacted...more

Health Care Weekly Preview from ML Strategies – April 2017

Welcome back everybody. While the momentum around an American Health Care Act (AHCA) comeback is unclear, there’s no discounting that efforts are ongoing to reach a consensus among House Republicans with significant pressure...more

The New England Compounding Center: The CEO of a Massachusetts Drug Company on Trial for Murder

by DLA Piper on

This was really a public health tragedy . . . I re- member feeling very scared.’’ This is how Dr. Benjamin Park, a division chief at the U.S. Center for Disease Control and Prevention (‘‘CDC’’), described the deadly...more

Enforcement Is On The Menu: May 5, 2017 Is The Deadline To Comply With Menu Labeling Rules

by Fox Rothschild LLP on

Over two years ago, on December 1, 2014, the U.S. Food and Drug Administration (“FDA”) published a food labeling rule requiring “chain” restaurants and similar retail food establishments to list calorie information on menus...more

Capitol Hill Healthcare Update

by BakerHostetler on

Although House Republicans made progress on bridging ideological differences over how to replace the Affordable Care Act (ACA), GOP leaders say not to expect a vote this week as Congress faces a more immediate deadline: The...more

Supreme Court Preview -- Sandoz Inc. v. Amgen Inc.

On Wednesday, April 26, the Supreme Court will hear oral arguments in the Sandoz Inc. v. Amgen Inc. case. This case involves the interpretation of the Biologics Price Competition and Innovation Act ("BPCIA"), which will be...more

FDA Advisory Committee to Hold Public Meeting on Hospira’s Proposed Epogen/Procrit Biosimilar

by Goodwin on

The FDA recently announced that the Oncologic Drugs Advisory Committee will hold a public meeting on May 25, 2017 to discuss Hospira’s application for a proposed biosimilar of Amgen’s Epogen®/Procrit® (epoetin alfa). Pfizer...more

St. Jude Medical On Hot Seat for Cybersecurity Flaws in Home Monitoring System

The Food and Drug Administration (FDA) recently issued a warning letter to St. Jude Medical, alleging that it failed to properly investigate issues with the batteries in its defibrillator implants and for failing to fix the...more

Dietary Supplement Advertising - April 2017

by Kelley Drye & Warren LLP on

State Regulation - CWAG Talks Dietary Supplements - At a gathering of the Conference of Western Attorneys General, a panel on “Regulatory Models and Transparency” focused on enforcement against USPlabs as a case...more

FDA Approval of 23andMe Genomic Test Shows the Way for Direct-to-Consumer Diagnostics

On April 6, 2017 the FDA Center for Devices and Radiological Health formally approved 23andMe’s Personal Genome Services Test as a Class II Medical Device. Approved tests include assessment of an individual’s genetic risk of...more

Congressional Committees Propose Restructuring of User Fees in Draft Language

by Morgan Lewis on

The draft language reauthorizes FDA’s authority to assess user fees and proposes fee restructuring and increases. On April 14, the health committees for both the US Senate and the US House of Representatives released a...more

What Does the Cures Act Really Mean for Patients?

When signed by President Obama last December, the 21st Century Cures Act—which was the culmination of seven revisions written after the House of Representatives first introduced it in January 2015—was applauded by some as a...more

Appeal for Legislative Action to Address REMS Concerns

by Goodwin on

Last month, during the Biosimilar and Generics User Fee Acts (BsUFA II and GDUFA II) reauthorization hearing, a subject of considerable discussion was Risk Evaluation and Mitigation Strategies (REMS). REMS is a provision...more

Uncertainty Abounds for Food Labeling Rules

In the next year, a number of pending FDA and USDA regulatory proposals threaten to upend the food manufacturing environment and may result in food and beverage companies being forced to change their labels (and possibly...more

New State Substitution Laws, and a Busy Spring for Biosimilars

We recently updated our chart that tracks state biosimilar substitution laws to include new laws in Iowa and Montana. These new laws bring the total number of states with biosimilar substitution laws to 27, plus Puerto Rico....more

FDA Relents, Grants Premarket Authorization to 23andMe Genetic Diagnostics Test

On April 6th, the U.S. Food and Drug Administration (FDA) continued to loosen the reins on the genetic diagnostic and DNA analysis company 23andMe with regarding to direct-to-consumer (DTC) genetic testing related to...more

WDNY Holds that Tysabri Warnings are Adequate as Matter of Law and that Product Liability Claims are Preempted

by Reed Smith on

However a drug/device product liability is styled, it will almost always be focused on a claim of failure to warn. Why do plaintiffs insist on inserting a cause of action for manufacturing liability when there is not a whiff...more

Congressional Leaders Seek Input in UFA Reauthorization Draft Bill by April 28, 2017

On April 14, 2017, leaders from the Senate HELP Committee and the House Energy & Commerce Committee released the first discussion draft of the 2017 FDA user fee reauthorization bill. As we’ve been reporting, these two...more

Menu Compliance Counts Starting May 5th

by Barley Snyder on

Restaurant calorie labeling: Starting next month, it’s not just for McDonald’s anymore. In an issue Barley Snyder has been tracking for years, the Food and Drug Administration is poised to begin enforcement of its...more

2,829 Results
|
View per page
Page: of 114
Cybersecurity

"My best business intelligence,
in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
Feedback? Tell us what you think of the new jdsupra.com!