News & Analysis as of

FD&C Act

Summary of FDA Guidance on Determining Whether to Submit an ANDA or a 505(b)(2) Application

On October 13, 2017, the U.S. Food and Drug Administration (FDA) released for comment, by December 12, 2017, draft guidance for industry entitled, Determining Whether to Submit an ANDA or a 505(b)(2) Application. The purpose...more

Quaker Oats Succeeds in Maple Syrup Suit

by Reed Smith on

The Central District of California granted Quaker Oats Company’s Motion to Dismiss a Consolidated Class Action Complaint on October 10. Plaintiffs alleged Quaker Oats Company was liable for labeling its “Maple & Brown...more

FDA Issues Guidance on Drug and Device Classifications

by Arnall Golden Gregory LLP on

On September 26, 2017, the Food and Drug Administration (FDA) announced the availability of a final guidance entitled Classification of Products as Drugs and Devices & Additional Product Classification Issues to clarify FDA’s...more

EPA Final Rule On Use Of TOFA Confirms Safety Of Unsaturated Fatty Acids

by Bergeson & Campbell, P.C. on

On October 10, 2017, the U.S. Environmental Protection Agency (EPA) published in the Federal Register its final rule establishing exemptions for a tolerance limit to use tall oil fatty acids (TOFA) as an inert ingredient...more

AGG Food and Drug Newsletter - October 2017

by Arnall Golden Gregory LLP on

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

You Can’t Change That: FDA Reiterates Risk of Delegating Responsibility in Quality Agreements

by Arnall Golden Gregory LLP on

In the span of three weeks, the Food and Drug Administration issued Warning Letters to two dietary supplement companies, in part, for relying, to their detriment, on quality agreements. We discussed another similar Warning...more

FDA and EPA Issue Joint Guidance On Jurisdiction Over Mosquito-Related Products

by Kelley Drye & Warren LLP on

Last week, FDA and the EPA issued guidance for industry regarding each agency’s respective jurisdiction over mosquito-related products. With the emergence of the Zika virus and the urgency in countering the spread of...more

AD-ttorneys@law

by BakerHostetler on

Abbott Nutrition did something unique. It added a new ingredient to its Similac Pro-Advance and Pro-Sensitive infant formulas that, until now, had only been available in human breast milk: 2’-fucosyllactose human milk...more

FDA Issues Long-Awaited Final Guidance on Interoperable Medical Devices

by Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) on Sept. 6, 2017, published the final version of its guidance on Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices. This final...more

FDA Reaffirms Its Commitment to the Approval of Stem Cell Therapies Amidst Enforcement Actions Against “Unscrupulous Actors”

The U.S. Food and Drug Administration (FDA or Agency) has become increasingly active in stem cell and regenerative medicine product regulation within the past year previously announcing that it would release a modified...more

FDA: Still in Action on Food Safety Violations

by Kelley Drye & Warren LLP on

Vigorous food safety enforcement for basic violations continues under the leadership of new FDA Commissioner, Dr. Scott Gottlieb. On June 20, on the heels of an adverse FDA inspection, FDA announced that the U.S. Marshals...more

Trump Administration Stands Firm on Prison Time for Strict Liability Offenses Under the Food, Drug, and Cosmetic Act

by Faegre Baker Daniels on

The Trump administration is urging the U.S. Supreme Court not to review the prison sentences given to Quality Egg LLC executives for their role in failing to prevent a national salmonella outbreak. This move indicates that...more

Certain Medical Devices Exempted from 510(k) Requirements

by Knobbe Martens on

The Food and Drug Administration (FDA) recently identified a list of Class II Medical Devices that, when finalized, will be exempt from premarket notification (510(k)) requirements. This publication was made by the FDA...more

February 2017: Life Sciences Litigation Update

Recently Amended FDA Rules Can Affect Settlements in Pharmaceutical Litigations. After more than thirteen years of bureaucratic analysis and rulemaking, the U.S. Food and Drug Administration recently implemented its new rules...more

AGG Food and Drug Newsletter - February 2017

by Arnall Golden Gregory LLP on

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

FDA Says Sharing Medical Product Information is Caring, to an Extent

FDA recently issued a draft guidance, “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities—Questions and Answers”, which is intended to bring clarity to a specific provision in...more

A&B Healthcare Week in Review

by Alston & Bird on

On January 9, 2017, the Food and Drug Administration (FDA) issued a draft guidance entitled, Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers; Draft...more

FDA Issues Draft Guidance Addressing Communications with Payors

by King & Spalding on

On January 18, the Food and Drug Administration (FDA or the Agency) issued a draft guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers. This...more

Radiopharmacies Celebrate the New Year with Long-Awaited FDA Guidance

by Reed Smith on

On December 29, 2016, the U.S. Food and Drug Administration (“FDA”) surprised many in the radiopharmacy industry by issuing a long-awaited draft guidance entitled “Compounding and Repackaging of Radiopharmaceuticals by...more

21st Century Cures Act Requires FDA to Expand the Role of Real World Evidence

As we noted in our December 9th post, the 21st Century Cures Act (the “Cures Act”) requires FDA to develop a framework and guidance for evaluating real world evidence (“RWE”) in the context of drug regulation to support...more

FDA Rule Formalizes Voluntary GRAS Notification System for Substances Added to Food

by Faegre Baker Daniels on

The U.S. Food and Drug Administration (FDA) has released its final rule “Substances Generally Recognized as Safe” (due for publication on August 17, 2016). Under the Federal Food, Drug, and Cosmetic Act, GRAS substances are...more

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

by Bergeson & Campbell, P.C. on

TSCA/FIFRA/IRIS/NTP/TRI - EPA Releases TRI Preliminary Dataset For Calendar Year 2015: On July 20, 2016, the U.S. Environmental Protection Agency (EPA) announced the availability of the Toxics Release Inventory (TRI)...more

New GMO Legislation Signed into Law

by Morgan Lewis on

With Congress’s freshly enacted GMO labeling bill, the devil is in the implementing details. On July 29, US President Barack Obama signed legislation that establishes a national disclosure requirement for identifying...more

President Obama Signs Federal GMO Law, Preempts Vermont Law

by K&L Gates LLP on

On July 29, 2016, U.S. President Barack Obama signed into law the first U.S. federal law requiring food manufacturers and distributors to label products that contain genetically modified organisms (“GMO”).[1] The law...more

Blog: All is Well:  FDA to Host Webinar on its Final Guidance for Low-Risk General Wellness Devices on September 1, 2016

by Cooley LLP on

The U.S. Food and Drug Administration (FDA) recently released final version of its guidance, General Wellness: Policy for Low-Risk Devices (Policy), with a webinar slated for September 1st as part of the rollout. While not...more

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