All News | FDA

Advertising & Promotion

Sep 15, 2015
Obama Nominates Dr. Robert M. Califf as Next FDA Commissioner
Sep 9, 2015
Pacira Invokes Amarin Injunction In Suit Over On-label Promotion
Sep 8, 2015
Genzyme Forking Over $32.5 Million To Settle Off-label Charges
Sep 1, 2015
Lawyers: FDA and Amarin in Settlement Talks
Sep 1, 2015
Kardashian Posts Corrective Ads To Social Media Accounts in Wake of FDA Warning Letter
Aug 27, 2015
FTC: FDA Should Abandon or Amend Regulatory Approach to Homeopathics
Aug 26, 2015
District Court Refuses to Set Aside Harkonen Wire Fraud Conviction
Aug 20, 2015
Amgen To Pay States $71 Million To Settle Off-label Promotion Claims for Two Drugs
Aug 19, 2015
Online Claims for Supplements, cGMP Problems Lead to Consent Decree Ordering Product Recall
Aug 12, 2015
Kim Kardashian’s Social Media Promotion Leads to Warning Letter for Duchesnay

Good Clinical Practice

Sep 28, 2016
California Gov. Signs ‘Right-to-Try’ Bill
Sep 28, 2016
Survey Details Five Top Factors in Clinical Investigator Compensation
Sep 28, 2016
Most Cancer Patients Interested in Trials Are Motivated by Clinical Benefit
Sep 27, 2016
FDA Examines Its Approach to Cancer Clinical Trials
Sep 26, 2016
All NIH-funded Trials Must Register, Report Results
Sep 26, 2016
Tools and Methods to Streamline Trials Is a CDRH 2017 Regulatory Science Priority
Sep 21, 2016
Website Provides User Reviews of Trials
Sep 21, 2016
HHS Releases Final Rule on Trial Registration and Result Reporting
Sep 12, 2016
Reps. Ask FDA for Better Guidance on Ancillary Financial Support for Subjects
Sep 9, 2016
ICH Provides Draft Guidance for Multi-regional Trials

FDA Regulation & Enforcement

Apr 5, 2019
Federal Court Allows Off-label Marketing Case Against Nine Former Aegerion Employees To Continue
Apr 5, 2019
CTP Sends Warning Letters to Two E-liquid Makers Over Misleading Labeling and Advertising
Apr 4, 2019
OMB Reviews FDA Plans for Electronic Submission of Promotional Materials
Apr 4, 2019
FDA Intends To Add Another NDC to ‘Dietary Fiber’ Definition
Apr 4, 2019
Arizona Reaches Settlement with Former Vice President of Sales for Insys
Apr 3, 2019
FDA Updates Device Establishment Inspection Processes, Standards in Response to FDARA Mandate
Apr 3, 2019
Drug Cost Transparency Legislation Introduced in Colorado House
Apr 3, 2019
Fresenius Agrees To Pay $231 Million To Resolve Widespread Foreign Corrupt Practices Violations
Apr 3, 2019
Montana House Approves Price Transparency Bill
Apr 3, 2019
FDA-FTC Sends Enforcement Letters to Three Companies Offering Cannabidiol Products Online

Medical Devices

Sep 30, 2010
FDA To Require PMA for Some Preamendment Devices
Sep 30, 2010
FDA Issues Device User Fee Rates for FY 2011
Sep 30, 2010
Industry Questions CDRH's Use of Guidances To Establish Major 510(k) Program Revisions
Sep 30, 2010
New Section Added to BIMO Guidance Covering International Inspections
Aug 31, 2010
Surgical Device Maker Warned For Off-label Promos
Aug 31, 2010
FDA, FCC Team To Ensure Safety of Wireless Devices
Aug 31, 2010
St. Jude To Pay Nearly $4 Million To Resolve Kickback Allegations Raised in False Claims Suit
Aug 31, 2010
Groups Propose Major Changes to 510(k) Program
Aug 31, 2010
IP Enforcement Plan Calls on Device Manufacturers To Notify FDA of Counterfeiting, Current Products
Aug 31, 2010
DOJ Issues Memorandum on Drafting DPAs, NPAs

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