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News & Analysis as of

In The Midnight Hour: FDA Issues 2 Draft Guidances and a First Amendment Memorandum on the Cusp of a New Administration

Over the past few days, FDA issued three documents related to the scope of permissible communications by drug and device companies to various parties. We believe FDA aimed to accomplish two things through these documents....more

OFAC Eases Restrictions on Medical and Agricultural Exports to Iran

On December 23, 2016, the Treasury Department’s Office of Foreign Assets Control (OFAC) issued a final rule amending the Iranian Transactions and Sanctions Regulations (ITSR) to expand the scope of permissible exports and...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FDA had a busy holiday season, issuing two final guidance documents and two draft guidance documents for industry related to human drug compounding right before the start of the new year.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

EPA Issues Changes to OCSPP Final Test Guidelines For Series 850 Group A—Ecological Effects

On December 29, 2016, the U.S. Environmental Protection Agency (EPA) issued a notice regarding the availability of final test guidelines, OCSPP Series 850 Group A -- Ecological Effects, part of a series of test guidelines...more

Happy New Year: OFAC Expands Exports of Medical Devices to Iran

Effective December 23, the Department of the Treasury’s Office of Foreign Assets Control (OFAC) amended the Iranian Transactions and Sanctions Regulations (ITSR) to expand the scope of medical devices that can be exported to...more

“Extra Sweet Pink Flesh Pineapple” – Oh My!

First off, I will admit that I am somewhat of a sucker for fresh pineapple (in fact, it was my “gorging” food of choice during my pregnancies, when I could literally eat a whole pineapple in one sitting – which is...more

Comments Due November 1, 2016 on Proposed Update to Framework for Biotechnology Regulation

On September 18, 2016, the Obama Administration issued two major documents in connection with its ongoing efforts to modernize the federal Coordinated Framework for the Regulation of Biotechnology. The first document, a...more

FDA Convenes Two-Day Public Hearing on Human Cell and Tissue Product Regulatory Paradigm

As stakeholders and watchers of the expansive field of regenerative medicine likely are aware, earlier this year a study published in the peer-reviewed journal Cell Stem Cell reported on the growth of so-called stem cell...more

Florida House Members Request Emergency Authorization to Combat Aedes aegypti Mosquitoes with Oxitec

On September 6, 2016, 61 members of the Florida House of Representatives issued a letter to the U.S. Department of Health and Human Services (HHS) and to the U.S. Food and Drug Administration (FDA) to urge them to: (1)...more

Forget About Vermont!: Congress Passes GMO “Labeling” Legislation

On July 14, 2016, the House of Representatives passed S.764 creating a National Bioengineered Food Standard. Importantly for food manufacturers and distributors, the law – expected to be signed by President Obama – will...more

FDA Issues Final Rule on Use of Symbols in Labeling

The Food and Drug Administration published a Final Rule in the Federal Register revising labeling regulations for medical devices and certain biological products to allow for the use of symbols without adjacent explanatory...more

Wrap-Up of Federal and State Chemical Regulatory Developments, June 2016

TSCA/FIFRA/IRIS/NTP/TRI - TSCA Reform Bill Is Sent To President Obama For Signature: It has been reported that on June 14, 2016, House Speaker Paul Ryan (R-WI) and Senate President Pro Tempore Orrin Hatch (R-UT) signed...more

FDA Clarifies Policy for Sharing Patient-Specific Data from Devices

Device manufacturers may share patient-specific information from a device with the patient without violating federal privacy requirements....more

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

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