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 -
News & Analysis as of

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

TSCA/FIFRA/IRIS/NTP/TRI - EPA Promulgates Final TSCA Reporting And Recordkeeping Rule For Nanoscale Materials: After over a decade of effort, the U.S. Environmental Protection Agency (EPA) issued on January 12, 2017, a...more

Blog: FDA Issues Discussion Paper on Laboratory Developed Tests

The U.S. Food and Drug Administration (FDA) issued today a Discussion Paper on Laboratory Tests (LDTs). The Discussion Paper follows draft guidance issued by the FDA in 2014 (2014 Draft Guidance) and a stakeholder workshop...more

FDA Releases Biosimilar Naming Guidance

FDA just released a final Guidance for Industry, “Nonproprietary Naming of Biological Products.” The guidance provides that naming for originator biological products, related biological products, and biosimilars should...more

2016 Year In Review: Securities Litigation And Regulation

2016 was an active year in securities litigation. In the first half of 2016 alone, plaintiffs filed 119 new federal class action securities cases. It was also a busy year for SEC enforcement proceedings, with a record 868...more

FDA Issues Final Guidance Requiring Meaningless Suffixes for Biosimilar Names

Despite nearly universal opposition from both biosimilar makers and innovator companies, FDA has issued final guidance adopting its controversial August 2015 proposal for naming biologics. Under the guidance adopted by FDA,...more

Bacteria Found in Cardiac Patients Linked to Heater-Cooler Machine

Heater-Cooler Machine Spreads Germs in Sterile Areas - The medical device sounds well-intended enough: a heater-cooler machine used during heart surgery to control a patient’s body temperature. Doctors employ them in the...more

FDA Issues Newest Guidance Regarding Biosimilar Application Process

On December 29, the U.S. Food and Drug Administration released its latest Guidance for Industry relating to the biosimilar application process set forth in the Biologic Price Competition and Innovation Act of 2009 (BCPCIA). ...more

FDA Finalizes Tobacco Product Intended Use Rules, Under a Risk of Rescission by Congress

As we’ve previously written about, 2016 represented a regulatory sea change for manufacturers, distributors, and retailers of e-cigarettes and other electronic nicotine delivery systems (ENDS), who became subject to FDA...more

Speculation of ANDA Product Launch Before FDA Approval Does Not Warrant Permanent Injunction

On December 28, 2016, Judge Stark of the District of Delaware, despite having previously found infringement, held that plaintiffs Bayer Pharma AG, Bayer Intellectual Property GmbH, and Bayer HealthCare Pharmaceuticals Inc....more

Food and Beverage News and Trends - January

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. Idaho ag-gag law back in court. In 2015, a federal court struck down...more

Beyond the Eleventh Hour: FDA Prepares to Finalize Intended Use Amendments Despite Midnight Rule Relief Act

On Monday, FDA issued a final rule to amend FDA’s established definitions of “intended use” for drugs and devices, the primary consideration in determining whether a product is regulated for a particular use and what...more

FDA Accepts aBLA for Mylan-Biocon’s Proposed Herceptin® Biosimilar

As we previously reported, in November Mylan and Biocon submitted an aBLA to the FDA for MYL-1401O, a proposed biosimilar to Genentech’s Herceptin® (trastuzumab). Today, Mylan announced that the FDA has accepted its...more

Happy Holidays from FDA: The Agency Issues Four Enforcement Letters for Unlawful Promotion

The Food and Drug Administration recently issued holiday gifts, in the form of enforcement letters, to four pharmaceutical companies. The letters are reminders that FDA is not in a partying mood when it comes to unlawful...more

FDA Issues Final Guidance on Postmarket Cybersecurity

Agency establishes a risk-based framework for assessment of postmarket cybersecurity risks for medical devices. On December 28, 2016, FDA issued a final guidance titled “Postmarket Management of Cybersecurity in Medical...more

Federal District Court finds brand-name manufacturer’s alleged regulatory delay tactics a valid theory of attempted monopolization

In a recent decision denying the defendant’s motion to dismiss, Judge Mitchell Goldberg of the Eastern District of Pennsylvania allowed the manufacturer of a generic version of Suboxone to proceed upon an interesting theory...more

“Regulatory Causation” Roundup

Last week’s Westlaw search (that’s one way we find the cases we discuss in the Blog) brought a blast from the past – a case almost three years old showed up discussing – and rejecting – expert testimony about so-called...more

Cannabis in animal supplements: A hazy proposition

Over at our Life Sciences Decoded blog, we have discussed the state of limbo in which animal dietary supplements exist from a regulatory perspective. In the case of human products, foods, dietary supplements and drugs occupy...more

Supreme Court Declines to Review Personal Jurisdiction Ruling in Drug Patent Case

In March 2016, a Federal Circuit panel issued a decision in Acorda Therapeutics Inc. v. Mylan Pharmaceuticals Inc. in which it held that Mylan was subject to specific personal jurisdiction in the District of Delaware because...more

White House Announces Release of Final Update to the Coordinated Framework for the Regulation of Biotechnology

On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology. The 2017 Update provides a comprehensive summary of the roles and...more

Ninth Circuit Revives “All Natural” Label Class Action, but Affirms Decertification of Damages Class

In an unpublished decision that is significant for both shoppers and consumer food companies, the Ninth Circuit recently reversed a district court’s ruling that the label “All Natural Fruit” is not likely to deceive...more

What the FDA has in store for the food industry in 2017

As Life Sciences Decoded looks forward in 2017, it is clear that FDA-regulated industries have a great deal of change confronting them. Last year, 2016, was a landmark year for the FDA and food regulations, as the agency...more

California Court Denies Stay of Consumer Class Action Challenging “Natural Cheese”

On December 6, 2016, United States District Judge John A. Kronstadt for the Central District of California denied a motion to stay a class action alleging violations of the UCL, FAL, and CLRA against Kraft Foods Group, Inc....more

Cyber Alert: 2016 Breach Roundup, Part II: U.S. and EU Data Breach Notification Regulations Highlights and Trends

Frameworks requiring breach notifications of various kinds significantly expanded in scope in 2016 at both the state and federal levels. However, at least in the U.S., some of the new federal requirements may not be in place...more

Human Drug Compounding: FDA Issues Four Guidance Documents

FDA had a busy holiday season, issuing two final guidance documents and two draft guidance documents for industry related to human drug compounding right before the start of the new year. These guidance documents cover...more

FDA Releases Guidance on Cybersecurity and Medical Devices

The FDA represents the latest federal agency to show a focus on cybersecurity issues with the release December 28 of new guidance. While the prospect of network-enabled medical devices increasingly offers the promise of...more

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