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 -

Merck Receives Tentative FDA Approval for Lantus Follow-on

by Goodwin on

On July 20, 2017, Merck & Co. announced that the FDA granted tentative approval of its 505(b)(2) application for Lusduna™ Nexvue™ (insulin glargine injection), its follow-on version of Sanofi SA’s Lantus. Merck’s product...more

Ninth Circuit Relies on Escobar to Revive False Claims Act Suit Against Pharmaceutical Manufacturer

On July 7, 2017, the U.S. Court of Appeals for the Ninth Circuit reversed a federal district court’s dismissal of a False Claims Act (FCA) whistleblower suit in United States ex rel. Campie v. Gilead Sciences, explaining that...more

AGG Food and Drug Newsletter - July 2017

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

You're Always a Day Away: DSCSA Product Identifier Requirements Delayed

by Arnall Golden Gregory LLP on

In recently issued draft guidance related to the implementation of product identifiers under the Drug Supply Chain Security Act ("DSCSA"), FDA has stated that it intends to exercise enforcement discretion for a period of one...more

Don’t give medical device makers more time before disclosing product woes

Pro-business and anti-consumer lawmakers in Congress are racing to slacken rules for medical device makers to report problems with their products. This move may imperil more patients, many of whom already have been harmed...more

Food and Beverage Alert: FDA Withdraws Food Coloring Draft Guidance

by Sherman & Howard L.L.C. on

The Alcohol and Tobacco Tax and Trade Bureau (TTB) reminded industry members last week that they must comply with TTB and Food and Drug Administration (FDA) requirements concerning food additives. In particular, the TTB...more

FDA Makes Two Announcements on Electronic Tracking of Prescription Drugs to Comply with the Drug Supply Chain Security Act

by Hogan Lovells on

On July 20, 2017, FDA published two announcements in the Federal Register related to the development of an electronic, interoperable system to identify and trace certain prescription drugs distributed within the United...more

Restaurants, Grocery Stores, and Convenience Stores Sue to Block New York City's Menu Labeling Rule

by Saul Ewing LLP on

The U.S. Food and Drug Administration’s (FDA or the Agency) decision a couple of months ago to delay its Menu Labeling Rule until May 7, 2018 was met with mixed reactions from industry. While the National Association of...more

FDA Creates Uncertainty by Delaying Nutrition Facts Label Compliance

by Pepper Hamilton LLP on

On June 13, the Food and Drug Administration announced it would indefinitely extend the compliance deadline for the Nutrition Facts Label final rules, creating uncertainty for food and beverage manufacturers....more

FDA Committee Recommends Approval of Bevacizumab and Trastuzumab Biosimilars

by Goodwin on

The FDA Oncologic Drugs Advisory Committee (ODAC) unanimously supported biosimilar versions of Roche’s cancer drugs Avastin (bevacizumab) and Herceptin (trastuzumab). Amgen and Allergan’s Avastin biosimilar candidate, ABP...more

When the Law Gives you Lemons: Will Citric Acid Make Good Lemonade for Plaintiffs? 

The food and beverage industry is faced with an onslaught of consumer fraud class actions targeting everything from the use of the terms “all natural,” “healthy,” and “organic,” to the amount of slack-fill in particular...more

Dietary Supplement & Cosmetics Legal Bulletin | July 2017

JAMA Study and Editorial Call for Improvements in Cosmetic Regulation and Surveillance - In response to a study analyzing adverse events for cosmetics and personal care products, the Journal of the American Medical...more

FDA House Legislation Would Relax Reporting of Medical Device Malfunctions

by Faegre Baker Daniels on

On July 12, 2017, the U.S. House of Representatives passed a bill to reauthorize four of the U.S. Food and Drug Administration’s user fees and to change various drug and device testing rules. H.R. 2430 – the FDA...more

Capitol Hill Healthcare Update

by BakerHostetler on

Delayed Senate Health Vote Boon to GOP or Just Prolonging the Inevitable? Senate Majority Leader Mitch McConnell’s announcement that he would delay a key procedural vote scheduled for this week on the Republicans’...more

First U.S. Avastin and Herceptin Biosimilars

On Thursday, July 13, 2017, FDA’s Oncological Drugs Advisory Committee (ODAC) unanimously recommended approval of biosimilars of two blockbuster cancer drugs. The first, Amgen and Allergan’s ABP-215, is a proposed biosimilar...more

NAS Publishes Report On Preparing For Future Products Of Biotechnology

by Bergeson & Campbell, P.C. on

On June 30, 2017, the National Academies of Sciences, Engineering, and Medicine (NAS) released the final version of its report Preparing for Future Products of Biotechnology, which is the result of a collaboration by a...more

Food & Beverage Litigation Update | July 2017

Cruz-Alvarez and Canfield Examine Recent Ruling on Website Access for Visually Impaired - Food and beverage companies offering retail sales on the web are facing a wave of lawsuits filed by visually impaired plaintiffs...more

Proposed Legislation to Relax Rules on Medical Device Reporting Passes U.S. House

by Cozen O'Connor on

On July 13, 2017, the U.S. House of Representatives passed a bill that would triple the amount of time in which medical device manufacturers are required to report certain malfunctions of some products to the Food and Drug...more

Wrap-Up of Federal and State Chemical Regulatory Developments, July 2017

by Bergeson & Campbell, P.C. on

TSCA/FIFRA - EPA Releases Final Test Guideline For Performance Against Bed Bugs: On June 14, 2017, the U.S. Environmental Protection Agency (EPA) announced the availability of a final test guideline, Laboratory Product...more

Minnesota Federal Judge Says Glyphosate Claims are “Unreasonable”

by Kelley Drye & Warren LLP on

A mini-trend in food litigation last year was the spate of class action cases alleging that foods advertised as “natural” contained trace amounts of the herbicide glyphosate. “Trace” is the operative word; to the extent...more

Second Circuit Allows Class Action Suit Involving Diabetes Drug to Proceed

by McDermott Will & Emery on

Purchasers of Takeda Pharmaceuticals Company’s branded diabetes drug, ACTOS, filed an antitrust suit alleging that Takeda falsely described two patents to the US Food and Drug Association (FDA) and, as a result, delayed...more

Court Dismisses Infringement Theory Premised on Speculated Future Formulation Changes

by McDermott Will & Emery on

The US District Court for the District of New Jersey granted generic manufacturer’s motion for judgment on the pleadings under Fed. R. Civ. P. 12(c) on the basis of non-infringement. Par Pharmaceutical, Inc. v. Luitpold...more

FDA Delays Enforcement of Prescription Drug Product Identifier and Related Requirements

Facing pressure from stakeholders and technological realities, the U.S. Food and Drug Administration has again delayed its enforcement of parts of the Drug Supply Chain Security Act (DSCSA). As we discussed in a prior post,...more

AGs Weave Themselves Into Patchwork of Digital-Health Regs

by Pepper Hamilton LLP on

There are more than 165,000 mobile health applications available for download in Apple’s App Store or Google Play. This number will likely keep rising, and a body of federal and state regulators, including state attorneys...more

The Deadline for Submitting Comments to USDA as it Prepares to Draft a Proposed Rule on GMO Labeling is Quickly Approaching –...

On June 28, 2017, the U.S. Department of Agriculture (USDA or agency) Agricultural Marketing Service (AMS) posted a list of 30 questions for consideration by stakeholders in order to assist the agency in developing a Proposed...more

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