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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 -

Ready to Release a New Pharmaceutical? What to Think About When Selecting Your Drug Name

by Foley & Lardner LLP on

Pharmaceutical name clearance in the United States can be complicated. This post aims to provide insight into the regulatory safety review process and the trademark registration process for candidate drug names. This...more

FDA Approves Zelboraf for Treatment of a Rare Cancer

by Knobbe Martens on

On November 6th, 2017, the U.S. Food and Drug Administration (FDA) approved the drug Zelboraf (vemurafenib), for the treatment of Erdheim-Chester Disease (ECD). The FDA approved Zelboraf under Priority Review, Breakthrough...more

Food, Dietary Supplement & Cosmetics Update | Vol. IV, Issue 7

by Jones Day on

USDA Inspector General Recommends Reform of AMS Organic Program for Imports - The USDA Inspector General ("IG") reviewed the Agricultural Marketing Service's ("AMS") process used in determining whether exporting...more

FDA Issues Warning Letters To Cannabidiol Product Manufacturers Over Health Claims

by Farrell Fritz, P.C. on

On November 1, 2017, the Food and Drug Administration (FDA) published a release concerning its issuance of warning letters to four companies concerning the marketing of products containing cannabidiol (CBD)....more

Biometric Data in the Workplace Could Trigger Privacy Litigation Wave

by Jones Day on

The Situation: While biometric data (such as fingerprints, facial recognition technology, and iris scans) can be used effectively in the workplace, privacy advocates worry that anonymity could be undermined, and plaintiffs'...more

FDA Issues New Guidance Documents on Regenerative Medicine but Delays Enforcement

by Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) announced a comprehensive framework for development and oversight of regenerative medicine products, including innovative cell-based therapies. ...more

AGG Food and Drug Newsletter - November 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 Publishes Supplemental Guidance on Menu Labeling for Chain Restaurants

by McDermott Will & Emery on

On November 7, the US Food and Drug Administration (FDA) published the latest in a series of industry draft guidance documents to help implement menu labeling and nutrient disclosure regulations applicable to chain...more

FTC Hosts Workshop – “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics”

by Mintz Levin on

On Wednesday, November 8, 2017 the Federal Trade Commission (FTC) hosted a workshop seeking to explore the general question of why the cost of prescription drugs has risen greatly in recent history. The Workshop was framed...more

10 Marketing Law Takeaways From ANA/BAA 2017

We just got back from the Association of National Advertising (ANA) and Brand Activation Association (BAA) Marketing Law Conference in Chicago, held earlier this week. With hundreds in attendance, and dozens of speakers...more

Restaurant Industry Gets Another Chance To Chime In On Menu Labeling

by Lewitt Hackman on

Franchisors in the food service industry have until January 18, 2018 to comment on the latest version of the Food & Drug Administration’s Menu Labeling Guidance. The FDA released the draft November 7th. This version includes...more

FDA Finalizes De Novo Evaluation Guidance and Issues Associated Refuse to Accept Checklist

by Hogan Lovells on

On October 30, 2017, the Food and Drug Administration (FDA or the Agency) released its final De Novo request guidance document entitled, De Novo Classification Process (Evaluation of Automatic Class III Designation) (Final...more

Wrap-Up of Federal and State Chemical Regulatory Developments, November 2017

by Bergeson & Campbell, P.C. on

TSCA/FIFRA - EPA Extends Comment Period For Draft Guidance For Pesticide Registrants On Notifications, Non-notifications, And Minor Formulation Amendments: On October 5, 2017, the U.S. Environmental Protection Agency (EPA)...more

FDA Releases New Guidance On Menu Labeling Rule

by Fox Rothschild LLP on

The Trump administration is moving forward with an Obama-era initiative requiring certain food establishments to list calorie information on menus and menu boards, including food on display and self-service food. The FDA...more

A “Surprise” Cosmetic Reform Bill Appears in Congress; Bipartisan Compromise Continues to Be Legislators’ Goal

As we predicted earlier this year, Congress is making moves toward enacting cosmetics reform legislation in the near future. In late October 2017, Senator Orrin Hatch (R-UT) introduced S. 2003, the “FDA Cosmetic Safety and...more

Pfizer Inc. v. Mylan Pharms. Inc.

by Robins Kaplan LLP on

Case Name: Pfizer Inc. v. Mylan Pharms. Inc., No. 15-79-GMS, 2017 U.S. Dist. LEXIS 125634 (D. Del. Aug. 9 2017) (Sleet, J.). Drug Product and Patent(s)-in-Suit: Toviaz® (fesoterodine fumarate extended-release tablets);...more

FDA Announces New Draft REMS Guidance

by Goodwin on

Last week, FDA Commissioner Scott Gottlieb announced new draft guidance on risk evaluation and mitigation strategies (REMS) programs. The draft guidance provides for a single shared Drug Master File submission for all...more

How to Pay the Piper: FDA Issues New Guidances for PDUFA VI and GDUFA II

by Arnall Golden Gregory LLP on

FDA recently issued two draft guidances: Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) and Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 (GDUFA II), which...more

FDA Issues Guidance on Submitting 510(k)s for Changes to Existing Devices

by Arnall Golden Gregory LLP on

On October 25, 2017, the Food and Drug Administration (FDA) issued a final guidance document, Deciding When to Submit a 510(k) for a Change to an Existing Device, which describes when a change in a medical device would...more

FDA Finalizes Policy for Sharing Patient-Specific Data from Medical Devices

by Reed Smith on

FDA recently released guidance (“Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request”) finalizing its policy on medical device manufacturers sharing patient-specific information...more

Three Years Later, Foley Survey Reveals Positive Prognosis for Telemedicine

by Foley & Lardner LLP on

When we launched Foley’s inaugural Telemedicine and Digital Health Survey in 2014, it was apparent that health care executives weren’t ready to make telemedicine a significant focus of their business and patient strategies....more

FDA Issues Final Guidance on "Deciding When to Submit a 510(k) for a Change to an Existing Medical Device"

Recently, the U.S. Food and Drug Administration (FDA) issued final guidance on deciding when to submit a new 510(k) premarket notification application for a change to an existing medical device. The guidance is far reaching...more

FDA Draft Guidance on Menu Labeling

by Foley & Lardner LLP on

On November 7, 2017, the Food and Drug Administration (FDA) released draft guidance regarding menu labeling requirements for certain chain restaurants and food establishments that are subject to the menu labeling requirements...more

FDA Issues Draft Guidance on Breakthrough Devices Program

The U.S. Food and Drug Administration (FDA) recently released draft guidance on the new "Breakthrough Devices Program," which was established by the 21st Century Cures Act. This new program supersedes and combines features of...more

Capitol Hill Healthcare Update

by BakerHostetler on

The year-end schedules of the Senate HELP and Finance committees just became more clogged, as the two panels will lead the review of President Trump’s nominee to be Health & Human Services (HHS) secretary. Trump announced...more

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