All News | FDA

Advertising & Promotion

Feb 11, 2017
Appeals Court Remands Case Over Company’s Faxed Invitation To Free Dinner Discussion for Physicians
Feb 10, 2017
Review of User-generated Reviews of Medicines Finds Positive Bias
Feb 9, 2017
Sales Rep Sentenced for Lying about Kickbacks
Feb 9, 2017
Conn. Drug Transparency Bill Introduced
Feb 7, 2017
NAD Finds ‘Clinically Proven’ Claims Supported for Sports Jelly Beans
Feb 7, 2017
Group Looks To Provide HCPs with Single Access to Pharmaceutical Industry Information
Feb 2, 2017
N.Y. Bill Eliminates Ad Expense Deduction, Calls for Marketing Cost Reporting
Feb 2, 2017
First Circuit Affirms Dismissal of Sales Reps’ False Claims Suit Alleging Off-Label Promotion
Feb 2, 2017
N.Y. Counties Sue Pharmaceutical Companies, Four Physicians over Opioid Promotions
Jan 30, 2017
Small Survey of Physicians Finds Patients Don’t Understand DTC Ads

Good Clinical Practice

Aug 18, 2017
FDA Issues MAPP on Emergency IND Process
Aug 18, 2017
Study Finds Number of Exclusion Criteria Growing in Lung Cancer Trials
Aug 18, 2017
IRBs Need To Rethink Payments to Research Subjects
Aug 18, 2017
JAMA Articles Raise Concerns About FDA Not Requiring RCTs in Some Cases
Aug 14, 2017
Final Rule on FDA Acceptance of Data from Device Studies Expected in December
Aug 14, 2017
CSDR Reaches 3,460 Trials
Aug 12, 2017
FDA Issues Guidance on Streamlining Development of Antibacterial Drugs for Patients with Unmet Needs
Aug 12, 2017
Studies To Support PMAs Lacking Age, Sex and Race/Ethnicity Reporting and Analysis
Aug 7, 2017
Survey Finds Discussion of Trials Between Doctors and Patients Should Be Standard of Care Treatment
Aug 4, 2017
ICH Begins Work on Targeted Safety Data Collection Guidance

U.S. Food Labeling

Apr 30,2011
FDA Seeking To Issue Proposed Rule on Modernized Nutrition Facts Label Before End of Year
Apr 30,2011
Minnesota Flatbread Maker Gets Warning Letter
Mar 31,2011
Welch Foods Agrees To Settle Lawsuits over Misleading Pomegranate Juice Marketing
Mar 31,2011
Kefir Maker Gets Warning Letter for Drug Claims
Mar 31,2011
Get Your Newsletter Faster Online!
Mar 31,2011
FDA Seeks Comment on Infant Formula Labeling Study
Mar 31,2011
Lawsuit Targets Dietary Guidelines for Downplaying Risks of Meat and Dairy Products
Mar 31,2011
Movie Theatre and Supermarket Groups Say They Should Be Excluded from Menu Labeling
Mar 31,2011
Media Characters on Food Packaging Shown To Influence Children's Taste Assessment
Mar 31,2011
FDA Invokes 'Jelly Bean Rule' in Warning Letter To Manufacturer of Calcium-Fortified Candy

FDA Regulation & Enforcement

Dec 26, 2019
Former Aegerion Sales Rep Convicted for Wire Fraud, Identity Theft Used in Insurance Fraud Scheme
Dec 26, 2019
Court Grants Injunction Against Arkansas Meat-labeling Law
Dec 24, 2019
District Court Allows False Ad Case to Continue
Dec 23, 2019
Payments, Meals and Travel Tied To Physician Prescribing Rates
Dec 21, 2019
Company Settles TGA Concerns Over Opioid Marketing to Health Professionals
Dec 20, 2019
Senate Bills Introduced Dealing with DTC Ads
Dec 19, 2019
Proposed Rule, Draft Guidance from FDA, HHS Offer Pathways for Importation of Lower-Cost Rx Drugs
Dec 19, 2019
Draft Instructions Posted for Validation of Methods To Detect Genetic Material for Labeling Under NBFDS
Dec 19, 2019
Survey Assesses Oncologists’ View of Company Interaction
Dec 19, 2019
Senators Ask Purdue To Reevaluate Its Incentive Program; Scrap CEO Bonus

Medical Devices

Dec 16, 2013
FDA Signals Possible Expansion of Medical Device Establishment Inspections by State Authorities
Dec 5, 2013
FDA Modifies Views on Intended Use of ‘Research Use Only,’ ‘Investigational Use Only’ IVD Devices
Nov 25, 2013
Warning Letter Calls on 23andMe Inc. To Withdraw Genetic Testing Product From the Market
Nov 19, 2013
CDRH Office of Compliance Reorganization Addresses Quality, Product Integrity
Nov 13, 2013
Draft Guidance From CDRH Outlines Voluntary Program for Qualifying Device Development Tools
Nov 13, 2013
FDA Issues Final Guidance on Device Pivotal Studies
Nov 7, 2013
Final Guidance on Pivotal Clinical Trials for Devices Released
Nov 6, 2013
Pilot Device Single Audit Program Begins in January
Oct 31, 2013
OIG: Hospitals That Use Spinal Devices From PODs Perform More Surgeries, May Boost Medicare Costs
Oct 24, 2013
FDA Updates eCopy Guidance, Addresses Common Submission Errors, Procedure for Resubmission

Copyright © Thompson FDA, a division of CBIS. All rights reserved.