News & Analysis as of

FD&C Act

FDA Issues Draft Guidance on Bulk Substances for Compounding by Outsourcing Facilities

by Holland & Knight LLP on

On March 23, 2018, the U.S. Food and Drug Administration (FDA) released draft guidance regarding the process through which it proposes to evaluate bulk drug substances nominated for use in compounding by outsourcing...more

FDA’s New Draft Guidance on Bulk Drug Substances in Compounding

This week, the U.S. Food & Drug Administration (FDA) published draft guidance, describing FDA’s policy and process for evaluating bulk drug substances used in compounding by outsourcing facilities that are registered under...more

Alston & Bird Healthcare Week in Review

by Alston & Bird on

Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more

Checklists and Guidance from FDA on the Acceptance Criteria for 510(k) Submissions

by Arnall Golden Gregory LLP on

FDA recently issued a final guidance on the Refuse to Accept Policy for 510(k)s (Guidance). The Guidance outlines the procedures and criteria FDA uses to determine whether a medical device premarket notification (510(k))...more

AGG Food and Drug Newsletter - January 2018

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 & FTC Issue Joint Warning Letters to Companies Marketing Products to Overcome Opioid Addiction and Withdrawal

by Kelley Drye & Warren LLP on

The FDA & FTC today posted warning letters to 11 marketers and distributors of opioid cessation products, alleging that such products were unapproved new drugs that violated the Federal Food, Drug and Cosmetic Act (FDCA) and...more

A Fine Line Between Prescription and Under a Doctor’s Supervision: The Case of Medical Foods and First Databank’s Classification

by Arnall Golden Gregory LLP on

In the 1984 movie, “This is Spinal Tap,” one of the characters utters, “It’s such a fine line between clever and stupid.” This classic line comes to mind as we review an issue involving First Databank Inc.’s (FDB’s) decision...more

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 Amends Regulations for 505(b)(2) Applications and ANDAs—Part I

As of December 5, 2016, the U.S. Food and Drug Administration (FDA) amended its regulations relating to the approval of new drugs. The FDA expects the amendments to reduce unnecessary litigation, reduce delays in the approval...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

How 21st Century Cures Act Affects Combination Products

In 2016, Congress enacted Section 3038 of the 21st Century Cures Act to amend the portions of the Federal Food, Drug and Cosmetic Act(FDCA) relating to the important and growing category of medical products that is...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

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