FFDCA

News & Analysis as of

EPA Publishes FIFRA Use Site Index for Antimicrobial Pesticides

On January 27, 2016, the U.S. Environmental Protection Agency (EPA) issued an Antimicrobial Pesticide Use Site Index (USI) to provide guidance to pesticide applicants and registrants under the Federal Insecticide, Fungicide,...more

EPA Posts Revised Antimicrobial Pesticides Use Site Index

On January 28, 2016, in docket EPA–HQ–OPP–2015–0302, the U.S. Environmental Protection Agency (EPA) posted its revised Antimicrobial Pesticide Use Site Index (USI). In the USI, EPA states that it “has developed [the USI] to...more

While Not Quite a Rash of Enforcement, FDA Takes Action in 2015 Against Cosmetic Products Making Unapproved Drug Claims

To paraphrase, admittedly horribly, the Cole Porter classic, “I’ve Got You Under My Skin,” a number of cosmetic companies got under the Food and Drug Administration’s (FDA) skin in 2015 for making unapproved new drug claims....more

FDA Issues Final Rule Amending Food Additive Regulations

On January 4, 2016, the U.S. Food and Drug Administration (FDA) issued a final rule amending its food additive regulations to no longer allow the use of three specific perfluoroalkyl ethyl-containing food contact substances...more

EPA Codifies New Changes to FIFRA Minimum Risk Pesticide Requirements

On December 28, 2015, the U.S. Environmental Protection Agency (EPA) finalized important changes to the “minimum risk” pesticide exemption under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)....more

EPA Revises Minimum Risk Pesticide Exemption Regulations

The final rule revising the U.S. Environmental Protection Agency (EPA) regulations governing the minimum risk pesticide exemption from pesticide registration requirements was published in the Federal Register on December 28,...more

"Key Takeaways: Fifth Annual Pharmaceutical and Medical Device Seminar"

On November 17, 2015, a group of Skadden attorneys and corporate counsel joined representatives from more than 20 life sciences companies to discuss U.S. enforcement issues companies throughout the industry face. The key...more

FDA Approves First Genetically Engineered Animal

On November 19, 2015, the U.S. Food and Drug Administration (FDA) announced it had approved AquaBounty Technologies' application for the genetically engineered (GE) salmon (AquAdvantage Salmon), the first time FDA has...more

EPA Requests Comments on Revocation of Chlorpyrifos Tolerances

On October 30, 2015, the U.S. Environmental Protection Agency (EPA) announced that it is requesting comments on a proposal to revoke all tolerances for the insecticide chlorpyrifos in response to a U.S. Court of Appeals for...more

EPA’s OCSPP Agrees to More Communication, Transparency, and Efficiency When Processing Pesticide Petitions

On October 27, 2015, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) issued a report on an evaluation conducted by OIG entitled “EPA Needs Policies and Procedures to Manage Public Pesticide...more

You Can Check Out Anytime You Want, But You Can Never Leave: FDA Import Detentions and Recommendations to Minimize Delays

In The Eagles’ song, “Hotel California,” Don Henley sings, “You can check out anytime you want, but you can never leave.” Life science companies can try to import all they want, but that doesn’t mean the products will make it...more

D.C. District Court Deals Blow to HHS 340B Program Interpretive Rule

Court says Congress has the power to make the change that HHS attempted with its Interpretive Rule, and thus it should be left to the legislative branch. A lawsuit challenging the Interpretive Rule, filed by the...more

Environmental Update – Proposed Hazardous Waste Rule for Pharmaceuticals

On August 31, 2015, the EPA proposed new regulations for the management of hazardous waste pharmaceuticals at healthcare facilities. First and foremost, the proposed rule prohibits the flushing of any hazardous waste...more

EPA Publishes Revised Fee Schedule for Registration Applications for FY 2016

On September 22, 2105, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register listing its revised registration service fees applicable to specified pesticide applications and tolerance...more

Don’t Flush the Drugs! The EPA is Coming!

The Environmental Protection Agency (EPA) recently issued a pre-publication Proposed Rule (40 C.F.R. part 266, subpart P) regulating the management and disposal of drugs deemed “hazardous waste pharmaceuticals” by healthcare...more

EPA Proposes New Standards for Hazardous Waste Pharmaceuticals

The Environmental Protection Agency (EPA) released its proposed Management Standards for Hazardous Waste Pharmaceuticals Rule. If finalized, it will create an entirely new subpart in the Resource Conservation and Recovery Act...more

Life Sciences Companies and Free %$&*@# Speech

Irish and NI life sciences companies operating in the US likely are familiar with the concept of “off-label” promotion–providing information about drug/device uses that have not been cleared by the FDA (even where the FDA has...more

Another One Bites the Dust: FDA Doesn’t Like the Fishy Smell of the Latest Court Decision on Off-Label Dissemination

In the most recent court decision, Amarin Pharma, Inc. v. United States Food and Drug Administration, No. 15 Civ. 3588 (PAE) (S.D. N.Y. August 5, 2015), a U.S. District Court granted Amarin's preliminary injunction to...more

First Amendment Protects Truthful Off-Label Speech by Drug Manufacturers

Pharmaceutical manufacturers have likely taken note of Amarin Pharma Inc.’s recent success in a pre-enforcement legal challenge against the Food and Drug Administration (FDA or the Agency). On August 7, 2015, Amarin obtained...more

FDA Cites Drug Company for Kim Kardashian Endorsement

This week might have been the first time that an FDA regulatory issue hit the headlines on TMZ and other “celebrity watcher” websites. In an August 7 Warning Letter sent to the drug company Duchesnay, Inc., FDA complains...more

Amarin Court Holds Truthful Off-Label Speech Entitled to First Amendment Protection

On August 7, 2015, the U.S. District Court for the Southern District of New York issued an opinion in Amarin Pharma, Inc. v. FDA, granting Amarin preliminary relief to engage in truthful and non-misleading off-label speech...more

International Food Law Gazette - July 2015

King & Spalding is pleased to provide this first edition of the International Food Law Gazette, a publication of our Food & Beverage Group. For decades, King & Spalding has closely advised leading food, beverage and dietary...more

Modernizing and Coordinating the Regulatory System of Biotechnology Products

On July 2, 2015, the U.S. Office of Science and Technology Policy (OSTP) of the Office of the President issued a memorandum to initiate a process to coordinate, update and modernize the federal regulatory system governing...more

FDA Issues Final Guidance on Intent to Exempt Certain Medical Devices from Premarket Notification Requirements

On July 1, 2015 the FDA issued its final guidance regarding the intent to exempt certain unclassified medical devices, certain Class II medical devices, and certain Class I medical devices that are subject to the reserved...more

FDA Gives Food Industry Three Years to Phase Out Partially Hydrogenated Oils from Food Products

On June 16, 2015, the Food and Drug Administration ("FDA") issued a declaratory order, requiring a phasing out of the use of partially hydrogenated oils ("PHOs"). In its order, the FDA stated that partially hydrogenated oils...more

44 Results
|
View per page
Page: of 2

"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 to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*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.
×