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Jan 11, 2021
N.Y. Assembly Bill Aims To Keep Individual Prescribing Data Confidential
Jan 6, 2021
FDA Debars Three Former Insys Executives
Dec 29, 2020
Senate Report Calls for Adding Payments to Tax-exempt Groups to Open Payments Database
Dec 21, 2020
Drug Company and Specialty Pharmacy Settle False Claims Act Case Over Payments to Foundations
Dec 16, 2020
OPDP Researchers Move Ahead with Endorsement Studies, Report on Completed Research
Dec 4, 2020
OPDP Issues Second Untitled Letter of 2020
Dec 2, 2020
Companies Settle FCA Case Over Improper Promotion of Drug-Device Combo Product for Pediatric Use
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

Good Clinical Practice

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
Oct 23, 2020
OHRP Allows Single IRB Review Exception for Some COVID-19 Research
Oct 20, 2020
Investigator Sentenced to More Than 28 Years for Falsifying Clinical Trial Safety and Efficacy Data
Oct 13, 2020
NHLBI Trial Changes Protocol and Informed Consent After Public Citizen Complaint to OHRP
Oct 8, 2020
NIH Launches COVID-19 Outreach Program Targeting Minority Communities
Oct 1, 2020
Study Finds Elderly Excluded from COVID-19 Trials
Sep 23, 2020
Revised Guidance Details Investigator Review of Safety Reports in Trials Conducted During Pandemic
Sep 16, 2020
FDA Issues Guidance on Measuring and Analyzing Common COVID-19 Symptoms in Clinical Trials
Sep 9, 2020
ACRO Publishes Manual and Toolkit for Conducting Decentralized Clinical Trials

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FDA Posts Draft Guidance on Voluntary Disclosure of Sesame as Allergen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

Medical Devices

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