All News | FDA

Advertising & Promotion

Sep 7, 2016
FDA’s Plan for Off-label Communications Hearing Met with Enthusiasm and Skepticism
Sep 7, 2016
NY County Sues Opioid Manufacturers, Saying Fraudulent Marketing Led to Abuse Epidemic
Sep 7, 2016
OPDP Issues Third Untitled Letter for 2016 over Exhibit Panel Promoting Investigational Drug
Sep 4, 2016
Conn. Majority Whip Pushes Transparency Law Detailing Drug Marketing Costs
Aug 31, 2016
SEC To Receive Over $5 Million To Resolve FCPA Allegations Involving AstraZeneca Subsidiaries
Aug 31, 2016
FDA Plans Two-day Hearing on Off-label Communications
Aug 30, 2016
District Court Finds Dietary Supplement Maker Made Unfounded Claims for Gray Hair Treatment
Aug 29, 2016
Illinois Sues Insys for Alleged Deceptive Sales of Opioid Painkiller, Seeks To Ban Company
Aug 26, 2016
PMCPA Chides Four Companies for ABPI Code Violations
Aug 26, 2016
Supplement Maker To Discontinue Claims

Good Clinical Practice

Apr 25, 2017
Curbing ‘Detrimental’ Research Practices Could Deter More Serious Research Misconduct
Apr 25, 2017
National Academies Report Recommends Creation of Research Integrity Advisory Board
Apr 22, 2017
Right-to-Try Bill Sent to Washington Governor
Apr 21, 2017
UC Students Scammed by Phony Trial Offers
Apr 21, 2017
Scientific Associations Need To Promote Research Integrity
Apr 20, 2017
Panel Offers Framework for ‘Site-less’ Trials
Apr 20, 2017
ClinicalTrials.gov Adds Final Rule FAQs
Apr 19, 2017
EMA Guideline Details Development, Maintenance and Retention of TMFs
Apr 19, 2017
Pa. House Approves Right-to-Try Bill
Apr 18, 2017
Right-to-Try Bill Sent to Iowa Governor

FDA Regulation & Enforcement

Sep 12, 2019
Mallinckrodt To Pay $15.4 Million To Settle Allegations of Paying Physicians To Prescribe Acthar
Sep 12, 2019
FDA Unveils New Submission System for Supplement NDINs, Claims
Sep 11, 2019
FTC Sends Warning Letters to Three Companies Over CBD Product Claims
Sep 11, 2019
U.S. Chamber, 13 States, and D.C. File Amicus Briefs Supporting Halt or Delay of Opioid ‘Bellwether’ Trials
Sep 9, 2019
Mallinckrodt Announces Tentative Settlement in Opioid Marketing Cases
Sep 9, 2019
Google Bans Ads for Unproven Medical Products
Sep 9, 2019
Texas Files Suit Against J&J Over Patch Marketing; 29 Texas Hospitals File Against Opioid Makers
Sep 5, 2019
Consent Decree Shuts Down Distributor of Drugs, Dietary Supplements Following Years of Violations
Sep 4, 2019
FDA Is Seeking Input on Updating Standards of Identity
Sep 4, 2019
South Dakota Adds Three Generic Drug Makers to Opioid Lawsuit

Medical Devices

Nov 1, 2012
GAO: FDA Must Focus on Device Information Security
Oct 1, 2012
Conflicting Opinion From Another California Superior Court Judge
Oct 1, 2012
Court: No Preemption of Off-label Device Claims
Sep 30, 2012
GHTF Releases Guidance for Reporting Adverse Events Resulting From Clinical Investigations
Sep 30, 2012
FDA Proposes Actions To Strengthen Postmarket Surveillance; New Uses of UDIs, Registries Planned
Sep 30, 2012
Congressmen Call on CDRH To Provide More Public Information on Safety of 510(k) Devices, Predicates
Aug 31, 2012
Draft Guidance Explains FDA Policy on Refusing To Accept 510(k)s; Early Acceptability Review Added
Aug 31, 2012
Court Dismisses False Claims Act Suit Based on Alleged Suppression of Adverse Event Reporting
Aug 31, 2012
Two Final Guidances on CADe Devices Issued
Aug 31, 2012
Device Maker Challenges FDA's Rejection of 510(k)s

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