FFDCA

News & Analysis as of

FDA Publishes Final Rule for Protection Against Intentional Adulteration as Part of Food Safety Modernization Act

FDA has published as part of the Food Safety Modernization Act (FSMA) a final rule concerning mitigation strategies to protect food against intentional adulteration. The rule will require domestic and foreign food facilities...more

New Compounding Policies from FDA May Affect Hospital and Health System Pharmacy Operations

Last month, FDA released three draft guidance documents that are expected to have significant implications for traditional pharmacy-based compounding and the distribution of those drug products....more

New Food Safety Whistleblower Regulations: OSHA Bites Off More Than It Can Chew

Seyfarth Synopis: Employers may face liability for retaliation charges from employees who report food safety issues under the Food Safety Modernization Act (FSMA). Employers in the food industry have a new headache to...more

FDA Issues Final Menu Labeling Guidance

The U.S. Food and Drug Administration (FDA) announced on 29th April the publication of its final guidance for industry, “A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods – Part II (Menu...more

Follow the Data: FDA Addresses cGMPs for Data Integrity Issues in Draft Guidance

The draft guidance provides insight into FDA’s expectations regarding data controls and compliance for pharmaceutical companies. In recent years, issues involving the integrity of and controls around manufacturing data...more

GMO Labeling Bill Stalls in U.S. Senate

Yesterday, the U.S. Senate failed to pass a bill sponsored by the chairman of the Senate Agriculture Committee, Pat Roberts (Rep. Kansas), that would prohibit state labeling laws and create federal standard for voluntary...more

Jury Trial Starts Today in POM v. Coca-Cola

POM Wonderful’s battle with Coca-Cola is nearing an end as a federal jury trial starts today in the long-running dispute. The case involves a now discontinued Coca-Cola product called “Minute Maid Enhanced Pomegranate...more

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

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