FDA

NIST Revises Intellectual Property Rights Offered to Federally Funded Inventions and Licensing of Government Owned Inventions

FDA

Judge Stark (D. Del.) Holds Generic Label is Insufficient to Prove Induced Infringement

FDA

Will Kratom Be Restricted?

FDA

FDA Proposes a New Risk-Based Enforcement Approach for Certain Categories of Homeopathic Drug Products

FDA

Menu Labeling Update: Plans On-Track for Implementation in May 2018

FDA

Menu Labeling Litigation Between the FDA and Public Interest Groups May Be On Hold

FDA

FDA Issues New Guidance on IRB Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations

FDA

The Deadline for Submitting Comments to USDA as it Prepares to Draft a Proposed Rule on GMO Labeling is Quickly Approaching – Submit your Comments Now.

FDA

U.S. Supreme Court Finds that Dancing with Biosimilars is NOT Mandatory

FDA

FDA Announces Intent to Extend Compliance Date for Changes to Nutrition and Supplement Facts Labels and Serving Sizes – Federal Register Notice to Follow “At a Later Date”

FDA

FDA Extends the UDI Compliance Date for Certain Class I and Unclassified Devices

FDA

New FDA Commissioner Scott Gottlieb, M.D. Sworn in Today

FDA

Compliance Deadline For Menu Labeling Regulation Postponed Due To Implementation Challenges; Further Request for Comments

FDA

A Roundup of Some of the Latest FDA News . . . . From DUNS Numbers to Cosmetics

FDA

FDA’s Public Meeting on the Use of the Term “Healthy” in the Labeling of Human Food Products - Summary and Major Takeaways

FDA

FDA to Hold Public Meeting to Discuss the Use of the Term “Healthy” in Food Labeling

FDA

FDA Recommends Maximum Level of Lead in Cosmetic Products . . . But Finds that Most Products Surveyed are Already Well Below the Recommended Levels

FDA

FDA Makes Public the Scientific Data Evaluated and Provides Draft Guidance Regarding the Inclusion of Certain Fibers in the Definition of Dietary Fiber

FDA

“Nutella” No Longer Just a Dessert Topping – FDA Seeks Comments on Appropriate Reference Amount Customarily Consumed (RACC) and Product Category for Flavored Nut Butter Spreads

FDA

Forty Years in the Making -- FDA Issues Propose Rule Requiring Electronic Submission of Labeling and Package Inserts for Class II and Class III Home-Use Medical Devices

FDA

FDA’s Hatch-Waxman Regulations Get a Long Overdue Update

FDA

FDA Seeks to Redefine the Term “Healthy” and Questions Whether this Could Help Consumers Make Better Food Choices

FDA

Just Use Soap and Water . . . . FDA Issues Final Rule on the Safety and Effectiveness of Antibacterial Soaps and Body Washes

FDA

Sandoz Wins FDA Approval for First Biosimilar of Amgen’s Enbrel®

FDA

FDA Issues Final Rule Extending the Compliance Dates for Certain Specific FSMA Provisions In Four of the Implementing Rules: All Other Compliance Dates Remain Unchanged.

FDA

Not Optional: Court Rules that Biosimilar Applicants Must Always Give Commercial Marketing Notice

FDA

The Push to Get Americans to Eat Healthier Continues – FDA Issues Voluntary Draft Guidance for Sodium Reduction in Processed and Restaurant Foods

FDA

Today is the Day - Final Regulations on Nutrition and Supplement Facts Labels and Serving Sizes Officially Publish in the Federal Register

FDA

What’s In a Name? FDA Releases Draft Guidance on Biosimilar Labeling

FDA

Amgen Opposes Supreme Court Review on Pre-Commercial Notice Provision in Amgen v. Sandoz But Files Cross-Petition on Whether Patent Dance Is Mandatory

FDA

With Deadline Looming for Vermont’s GMO Law, Will Congress Pass Legislation to Address GMO Labeling?

FDA

On the Last Day Sandoz Files Writ of Certiorari Requesting Supreme Court Review

FDA

China Aims to Consolidate Drug Market, Support Larger Role for Traditional Chinese Medicines

FDA

Sandoz Ramps Up Biosimilar Program: European Biosimilar Application of Amgen’s Neulasta® Accepted; Acquisition of Pfizer Infliximab Biosimilar

FDA

FDA Continues to Grapple with Strategies for Tackling Medical Device Cybersecurity Vulnerabilities

FDA

Supreme Court Review in Amgen v. Sandoz – Amgen Decides not to Seek Review; Sandoz is Granted Filing Extension

FDA

BIO and PhRMA Citizen Petition Calls For Detailed Information on Biosimilar Labeling

FDA

AbbVie to FDA: Clinical Support Needed For All Reference Product Approved Indications to Support Interchangeability Designation for Biosimilars

FDA

Amgen v. Apotex: 180-Day Advance Notice of Biosimilar Marketing is Mandatory

FDA

Amgen Files First Marketing Authorization Application for Humira® in the EU

FDA

Amgen Files Application for Humira Biosimilar

FDA

CMS Announces Comprehensive Care for Joint Replacement Model:VTAgency Includes Waivers for Telehealth

FDA

21st Century Cures Act Passed by the House…Next up, the Senate

FDA

CMS Issues the CY2016 Proposed Physician Fee Schedule: the First Proposed Adjustments Following the SGR Repeal

FDA

The Affordable Care Act Lives On

FDA

Down to the Wire: FDA Extends Deadline for Dispenser’s Product Tracing Requirements Less than 24 Hours Before July 1, 2015 Deadline

FDA

CMS Finalizes the Categories of ACOs Eligible to Obtain Reimbursement for VTCertain Telemedicine Services

FDA

Senate Passes Repeal of SGR Physician Payment Formula

FDA

Stabilizing Physician Payment: H.R. 2 and Alternative Payment Models

FDA

U.S. Supreme Court Rules State Boards Not Precluded From Antitrust Scrutiny

FDA

9th Cir. Backs FTC Hospital Merger Challenge

FDA

First Biosimilar Recommended for Approval by FDA

FDA

CMS Announces Modified Meaningful Use Requirements

FDA

FDA Issues Final Cybersecurity Guidelines

FDA

HIPAA Clarity for the Mobile Health Industry