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

On Alternative Design, Take Two - Negligence

Back in 2013, inspired by a win of our own that we were actually allowed to blog about, we put up a post entitled “On Alternative Design.” Taking the alternative design requirement for strict liability as a given, we...more

Capitol Hill Healthcare Update

Meeting privately with Senate Republicans to discuss next steps on the ACA was among the first actions taken last week by the new Secretary of the U.S. Department of Health and Human Services Tom Price. But GOP senators left...more

Will You, Won't You Join The Biosimilar Patent Dance?

In the latest dispute surrounding the “patent dance” provisions of the Biologics Price Competition and Innovation Act (BPCIA), Genentech, Inc. has filed a complaint against Amgen, Inc., alleging that after opting into the...more

Sixth Circuit Affirms Branded Drug Preemption and Trial Win

In the aftermath of Levine, with its generous interpretation of the CBE regulation and its novel “clear evidence” standard, we wondered how long it would be until we saw a court holding that a failure to warn claim with a...more

Food and Beverage News and Trends - February 2017

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. California judge finds Roundup to be a possible cause of cancer. On January...more

Biosimilars Council Files Amicus Brief in Sandoz v. Amgen

As we covered in a previous post, in April the Supreme Court will hear arguments regarding the BPCIA’s notice of commercial marketing requirement and patent dance provisions. Last week, the Biosimilars Council filed an amicus...more

United States Amicus Brief Filed in Sandoz v. Amgen

Last week the Office of the Solicitor General (“SG”) filed an amicus brief on behalf of the United States in support of Sandoz’s position with respect to the BPCIA’s notice of commercial marketing requirement and patent dance...more

Insider Trading Around Private Placements: Was Tom Price’s Investment Down Under Above Board?

On February 10, the Senate confirmed Representative Tom Price (R-GA) as Secretary of Health and Human Services, where he will oversee the U.S. Food and Drug Administration (FDA). His nomination has not been without...more

Reexamination of “Healthy” Continues with an FDA Public Meeting in March 2017

As we’ve previously reported, FDA has signaled its interest in reviewing the scope and meaning of the nutrient content claim “healthy,” in part as result of a dispute with KIND LLC about label claims for its KIND Bar...more

FDA Changes Warning For Fluoroquinolones

Fluoroquinolones is a drug used to treat respiratory and urinary infections. Fluoroquinolones include these drugs: - Avelox (moxifloxacin); - Cipro (ciprofloxacin); - Cipro extended-release (Cirpofloxacin...more

FDA Hardens Its Stance on Intended Use and Off-Label Use and Industry Responds

From 2015 to 2016, FDA appeared to open the door to loosening the standards around intended use and off-label use, but recent rule-making and public comments suggest that FDA is becoming more sclerotic instead of flexible....more

Major Effects of Revised Common Rule on Regulation of Clinical Research in New York

On January 19, 2017, the U.S. Department of Health and Human Services (HHS), together with 15 other federal Departments and Agencies, issued a final rule to revise and modernize the federal Policy for the Protection of Human...more

FDA to Hold Public Meeting to Discuss the Use of the Term “Healthy” in Food Labeling

The Food and Drug Administration (FDA or agency) announced this week that it will be hold a public meeting on March 9, 2017, from 8:30 a.m. to 5:30 p.m., to discuss the use of the term “healthy” in the labeling of food...more

Six Key Changes to the Common Rule

On January 19, 2017, sixteen federal agencies, including the Departments of Health and Human Services and Labor, published the first revision to the federal regulations governing the protection of human subjects participating...more

AGG Food and Drug Newsletter - February 2017

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

Federal Trade Commission Deploys Antitrust Weaponry Against Pharmaceutical Company

In Federal Trade Commission v. Shire ViroPharma Inc. (D. Del. Feb. 7, 2017), the FTC has, for the first time, deployed its antitrust weaponry against a pharmaceutical company’s alleged practice of using the FDA’s...more

TrumpCare: The Pharmaceutical Industry and FDA

Hope in the Midst of Uncertainty - The New Year ushered a period of uncertainty for the pharmaceutical industry. We face the beginning of the Trump Administration and a Congress with both houses controlled by Republicans...more

Genentech Files DJ Action Against Amgen Regarding Avastin Biosimilar

Big Molecule Watch frequently posts on BPCIA litigation. As our readers know, the interpretation of various provisions of the BPCIA is currently before the Supreme Court in Sandoz v. Amgen, which we most recently covered...more

Biosimilar Litigants Square Off Before the Supreme Court

Last week, Sandoz filed its opening Supreme Court brief, asking the Court to determine (1) whether notice of commercial marketing under Subsection (l)(8)(A) of the Biologics Price Competition and Innovation Act (“BPCIA”) is...more

Food for Thought: A Review of 2016 Litigation

Food for Thought is a review of significant court decisions affecting the food, beverage, dietary supplements and personal care products industry. Although many cases in this edition focus on class certification, others...more

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

TSCA/FIFRA/NTP - EPA Proposes Regulation Of TCE Use In Vapor Degreasing Under TSCA Section 6(a): On January 19, 2017, the U.S. Environmental Protection Agency (EPA) issued a proposed rule under Section 6(a) of the...more

FDA Hits “Pause” on Regulation of LDTs

On January 13, 2017, the U.S. Food and Drug Administration (FDA) issued a Discussion Paper on Laboratory Developed Tests (LDTs) (LDTs) (Discussion Paper). The Discussion Paper follows FDA’s late 2016 announcement that,...more

FDA Accepts Mylan aBLA or Pegfilgrastim Biosimilar

Mylan N.V. and Biocon Ltd. have announced that the FDA has accepted Mylan’s Biologics License Application (BLA) for MYL-1401H, a proposed biosimilar to Amgen’s Neulasta® (pegfilgrastim), for filing through the 351(k)...more

Summary of Sandoz’s Opening Brief in Sandoz v. Amgen

Sandoz filed its opening brief to the Supreme Court on Friday, February 10, 2017. The dispute focuses on the notice marketing provision and the information exchange or “patent dance” procedures of the Biologics Price...more

Decoding New FDA Nutrition And Supplement Facts Guidance

The U.S. Food and Drug Administration continues to fulfill its promise to provide food and dietary supplement companies with additional guidance on complying with the new final rules amending nutrition facts label...more

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