All News | FDA

Advertising & Promotion

Oct 31, 2020
District Court Dismisses FCA Case Over Alleged Off-Label Marketing of Cancer Drug
Oct 23, 2020
DOJ Reaches Global Settlement with Purdue Pharma
Oct 20, 2020
Former Supplement Company Executives Sentenced to Prison Terms for Roles in Fraudulent Marketing
Oct 16, 2020
Details of Mallinckrodt’s Global Opioid Settlement Released
Oct 15, 2020
Gilead To Pay $97 Million To Resolve Kickback Allegations over Foundation Copays
Oct 15, 2020
Former Compliance Officer’s Qui Tam Suit Leads to $18 Million Settlement with Merit Medical Systems
Oct 4, 2020
OPDP Issues Two More Warning Letters
Sep 29, 2020
Abrams Retires from OPDP
Sep 23, 2020
Proposed Rule Outlines Evidence Relevant to FDA’s Determination of Intended Uses of Medical Devices
Sep 20, 2020
OPDP Researchers To Examine Medical Conference Attendees’ Observations on Drug Promotion

Good Clinical Practice

Jan 19, 2021
Recorded Phone Trial Recruitment Pitches Are OK
Jan 12, 2021
Investigator Pleads Guilty to Conspiring To Falsify Trial Data
Jan 6, 2021
FDA Issues Guidance on Individualized ASO Drug Trials
Dec 29, 2020
DOJ Cites Iowa Center for ‘Uncontrolled and Unsupervised Experimentation’
Dec 23, 2020
Master Protocols Added to Final FDA CID Guidance
Dec 16, 2020
HHS Seeks SACHRP Nominations
Dec 10, 2020
FDA Recommends How To Ensure Proper IP Disposal During Pandemic
Nov 30, 2020
FDA Draft Guidance Offers Recommendations for DDI Studies with COCs and Acid-Reducing Agents
Nov 22, 2020
PhRMA Issues Guidance for Enhancing Trial Diversity
Nov 17, 2020
FDA Issues Final Guidance on Certificates of Confidentiality

U.S. Food Labeling

Jan 7,2021
ANPR Issued on USDA’s Oversight of Genetically Engineered Animals
Jan 7,2021
Petition Seeks Dietary Fiber Consideration for Gum Acacia
Jan 7,2021
FDA Sets New Food Labeling Uniform Compliance Date
Jan 7,2021
Supplement Firm Owner Pleads Guilty to Drug Distribution
Jan 7,2021
FDA Warns Retailer About Undeclared Allergens
Dec 23,2020
FDA Finalizes Labeling Guidance on Alternate Name for Potassium Chloride
Dec 10,2020
Court Refuses To Enjoin Oklahoma Plant-Based Meat Labeling Law; Plaintiffs Appeal
Nov 24,2020
House Passes Bill To Add Sesame to Regulated List of Allergens
Nov 12,2020
FDA Posts Draft Guidance on Voluntary Disclosure of Sesame as Allergen
Oct 29,2020
FDA Wants Feedback on Labeling ‘Nontraditional’ Sugars

FDA Regulation & Enforcement

Jan 13, 2021
Court Shuts Down Supplement Company That Claimed Its Vitamin D Products Could Treat COVID-19
Jan 11, 2021
N.Y. Assembly Bill Aims To Keep Individual Prescribing Data Confidential
Jan 7, 2021
Congress Expands FDA’s Administrative Destruction Authority To Include Imported Medical Devices
Jan 7, 2021
ANPR Issued on USDA’s Oversight of Genetically Engineered Animals
Jan 7, 2021
Petition Seeks Dietary Fiber Consideration for Gum Acacia
Jan 7, 2021
FDA Sets New Food Labeling Uniform Compliance Date
Jan 7, 2021
Supplement Firm Owner Pleads Guilty to Drug Distribution
Jan 7, 2021
FDA Warns Retailer About Undeclared Allergens
Jan 6, 2021
FDA Debars Three Former Insys Executives
Dec 29, 2020
Another Supplement Company and its Owner Plead Guilty to Charge of Marketing Unapproved SARMs

Medical Devices

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