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Advertising & Promotion

Nov 24, 2020
OPDP Adds Five-day Screening Period to Core Launch Review
Nov 17, 2020
HHS OIG Issues Special Fraud Alert on Speaker Programs
Nov 8, 2020
Medtronic Agrees To Pay $9.2 Million To Settle FCA Case
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

Good Clinical Practice

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FDA Draft Guidance Offers Recommendations for DDI Studies with COCs and Acid-Reducing Agents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
Nov 10, 2020
FDA Issues Final Guidance on Trial Diversity
Nov 2, 2020
SACHRP Recommends that HHS Narrowly Interpret Revised Common Rule Exclusion of Public Health Surveillance

U.S. Food Labeling

Jun 13,2019
AMS Clarifies Certification of Organic Crop Container Systems Under NOP
Jun 6,2019
FDA Recommends Use of ‘Best if Used by’ on Date Label
May 29,2019
FDA Is Closer to Regulating ‘Healthy,’ While ‘Natural’ Continues to Play Out in Court
May 23,2019
Draft Guidance Would Allow Alternative Name for Potassium Chloride
May 16,2019
Lawsuit Challenges FDA’s Ban on the Supplement Ingredient DMHA
May 9,2019
Stakeholders Want Details on Labeling Cell Cultured Food
May 1,2019
FDA Seeks Input on Cannabis as Food, Supplement Ingredient
May 1,2019
AMS Makes Changes to National List
May 1,2019
FSIS Proposes To Amend Dual Content Regulations
Apr 25,2019
FDA Modifies Mandatory Labeling Declaration for Allulose

FDA Regulation & Enforcement

Medical Devices

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