The United States Food and Drug Administration

The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the... more +
The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the passage of the 1906 Pure Food and Drugs Act. The agency is charged with protecting the integrity of the nation's food supply and cosmetic products, as well as monitoring the safety and efficacy of drugs, medical devices, and biological products.  less -
News & Analysis as of

Questions About FDA’s Drug Approval Process Answered

The road to U.S. Food and Drug Administration approval of pharmaceutical manufacturers’ medications is a long and winding one. A dynamic process tinged with favorable – and unfavorable – factors can take a drug from lab to...more

FDA Issues Final Rules That Change Nutrition Facts Labels

No more sugar coating—the Rules impose new label requirements, and manufacturers will incur additional costs. The US Food and Drug Administration (FDA or the Agency) has announced the issuance of two new final rules: one...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

GPhA Responds to PhRMA/BIO’s Joint Citizen Petition Regarding Biosimilar Labeling

As we previously reported, in late 2015, the Pharmaceutical Research and Manufacturers of America (“PhRMA”) and Biotechnology Industry Organization (“BIO”) trade associations jointly submitted a Citizen Petition asking the...more

FDA takes Kind Approach to “Healthy” Corporate Philosophies

This month, FDA showed a willingness to catch up with the recent trends, advancements, and developments in the food and beverage industry by reconsidering years-old regulations regarding products labeled as...more

New FDA Draft Guidance on the Use of Electronic Health Record Data in Clinical Investigations

FDA emphasizes interoperability and outlines other best practices for effectively using EHR data in FDA-regulated studies. Acknowledging the increased use of electronic health records (EHRs) in clinical studies, and the...more

FTC Maintains Aggressive Stance Against Pay-for-Delay Deals

A recent complaint filed by the Federal Trade Commission (FTC) indicates that the agency is continuing its aggressive pursuit of agreements between drug manufacturers that delay the entry of generic pharmaceuticals into the...more

Food and Beverage News and Trends - May 2016 #2

Report finds no danger to human health in consumption of GMOs. In a 388-page report released May 17, the National Academies of Sciences, Engineering and Medicine said it has found no evidence of adverse health effects in...more

Talc Litigation: The Big Picture

In 2015 and 2016, juries awarded $13 million in a talc case in California, and $72 million and $55 million in talc cases tried in Missouri. The California plaintiff argued that she used talcum powder which contained...more

Administration Releases Spring 2016 Regulatory Agenda with Timeline for Rulemaking

The Obama Administration has posted its updated 2016 regulatory agenda, which lists major pending or planned rulemaking and the expected timing for action. The latest agenda includes numerous rules in the pipeline impacting...more

Stick a Fork in It – FDA Anti-Generic Drug Preemption Proposal Postponed Until After the Presidential Election

On May 18, the FDA extended the comment period for its proposed generic drug labeling rule until April 2017 – that is, until after the next presidential election. We believe that, for all practical purposes, this means that...more

FDA releases long-awaited nutrition facts panel, serving size final rules: key changes to food labels

The FDA has released the long-awaited Nutrition Facts Panel and Serving Size Final Rules, after initially proposing the changes in March 2014. The associated label changes, which mark the first time since 1993 that the...more

FDA Accepts Samsung Bioepis’s BLA for Remicade® Biosimilar

Samsung Bioepis Co., Ltd., announced that the FDA has accepted its first biosimilar application submitted in the United States. The candidate, SB2, references Janssen’s Remicade® (infliximab), which treats several ailments,...more

USA vs. Europe: Patients Hang in Balance as Big Pharma Reports Drug Side Effects Differently to FDA, EMA

A newly published study shows that drugmakers are doing a disservice to patients by inconsistently reporting side effects of medications depending on whether the information is being filed with the U.S. Food and Drug...more

Patient and Provider Groups Urge FDA to Institute Meaningful and Memorable Names for Biosimilars

A coalition of patient and provider groups sent an open letter to Leah Christl, FDA’s associate director for therapeutic biologics and biosimilars, urging FDA to use meaningful names for biosimilars instead of random ones. ...more

FDA to Issue Revised Guidance on Nutrition and Supplement Facts and Serving Size Regulations

This Friday, May 27, 2016, the US Food and Drug Administration (FDA) will publish its revised Nutrition and Supplement Facts and Serving Size regulations. The Serving Size regulation in public inspection view is close to 180...more

NIH takes stronger steps to improve patient safety at Bethesda Clinical Center

Federal officials have decided to sweep out the executive ranks at the flagship hospital of the National Institutes of Health in Bethesda, this after a blue-chip investigating committee rebuked the institution and declared...more

FDA Finalizes Revisions to Nutrition/Supplement Facts Labeling

On Friday, May 20, the United States Food and Drug Administration (FDA), an agency within the U.S. Department of Health and Human Services, announced its final revisions to the labeling requirements for conventional foods and...more

Prepare Now to Comply With FDA's Changes to Nutrition Labeling

On May 20, 2016, the U.S. Food and Drug Administration (FDA) announced that it finalized new rules that will cause the most significant overhaul to nutrition labeling in more than 20 years. FDA is issuing two final rules: (1)...more

FDA Releases Final Rules Revising Nutrition Facts Label and Certain Serving Sizes; Industry Given Two to Three Years to Comply

FDA announced on May 20th, 2016, that it was finalizing two previously proposed rules that will require industry to overhaul Nutrition Facts panels on all food products sold in the United States and recalculate serving sizes...more

FDA’S Draft Guidelines for 3D Printing of Medical Devices

On May 10, 2016, the FDA issued a document entitled Technical Considerations for Additive Manufacturing Devices. The document consists of 25 pages of “draft” guidelines that provide the FDA’s “initial thinking on...more

FDA Issues Interim Response to UAW’s Citizen Petition on Biosimilar Labeling

As we previously reported, UAW Retiree Medical Benefits Trust and affiliated funds filed a Citizen Petition on November 2, 2015 asking FDA to adopt a “same labeling” approach for biosimilar labeling. On May 19, 2016, FDA...more

FDA Issues “Leapfrog” Draft Guidance for 3D Printing of Medical Devices

3D printing raises significant technical considerations for device manufacturers. In response to the increasing use of 3D printing in the medical device arena, on May 10, the US Food and Drug Administration (FDA or...more

AGG Food and Drug Newsletter - May 2016

Arnall Golden Gregory LLP's (AGG) 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...more

Legal Update: Regulation of E - Cigarettes

On May 5, 2016, the federal Food and Drug Administration (FDA) announced new regulations governing the sale of e-cigarettes, hookahs, dissolvable tobacco, pipe tobacco, cigars and other tobacco products (ENDS). The new rule...more

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