All News | FDA

Advertising & Promotion

Dec 20, 2016
PMCPA Cites Five Companies for ABPI Code Breaches
Dec 19, 2016
Dismissal of Suit Alleging That Device Firm Promoted Unnecessary Battery Replacements Is Affirmed
Dec 16, 2016
Forest Agrees to Pay $38 Million to Resolve Kickback Allegations Over Speaker Program
Dec 15, 2016
OPDP Releases Four Enforcement Letters in Two Days
Dec 15, 2016
Don’t Expect Big Changes in FDA Off-label Communications Policy
Dec 14, 2016
FDA Extends Off-Label Communications Comment Period to April 10
Dec 13, 2016
FTC Settles with Blood-Pressure App Marketers, Issues Decision Against Sunscreen Manufacturer
Dec 9, 2016
NAD Recommends Two Companies Discontinue Claims; Third Company Asked to Modify Claims
Dec 6, 2016
Cures Bill Allows Manufacturers To Provide Health Care Economic Info to Payers
Nov 30, 2016
FDA Moves Ahead with Study of ‘Supers’ in DTC Promotion

Good Clinical Practice

Jul 13, 2017
GAO: FDA Needs To Explain How It Uses AE Info Received from Expanded Access
Jul 10, 2017
Hospital Plan To Reduce or Waive Study Co-pays for Needy Medicare Subjects Passes OIG Scrutiny
Jul 10, 2017
EMA To Update Vaccine Development Guideline
Jul 7, 2017
CDER Officials Examine Use of Master Protocols
Jul 6, 2017
Two Reps. Question Consent Issues in NHLBI Study
Jul 6, 2017
NIH Pushes Back Single IRB Policy Again; Implementation Now Set for January 2018
Jul 6, 2017
AMIA Asks Feds Lift Freeze on Revised Common Rule And Not Delay January 2018 Implementation Date
Jul 6, 2017
EMA and FDA Suggest Use of Multi-company Clinical Trials for Rare Pediatric Disease Treatments
Jun 30, 2017
CTTI Issues Recommendations and Tools to Integrate Mobile Technology into Clinical Trials
Jun 30, 2017
ClinicalTrials.gov Now Accepting Protocols and Statistical Analysis Plans

U.S. Food Labeling

Dec 31,2010
Product Recalls
Dec 31,2010
Family Purchases of Organic Products Remain Robust, Says New Study
Dec 31,2010
FDA To Hold Labeling Workshop, Mar. 3-4
Nov 30,2010
NAD Finds Fault with New Chocolate Cheerios Ad
Nov 30,2010
Chiquita Gets FDA Warning Letter for Multiple Labeling Violations in Pineapple Products
Nov 30,2010
Product Recalls
Nov 30,2010
Food Industry To Launch FOP Labeling Initiative
Nov 30,2010
WTO Panel To Hear COOL Dispute Pitting U.S. Against Canada and Mexico
Nov 30,2010
Bottled Water from Iceberg Gets Temporary Permit
Nov 30,2010
Federal Preemption Wins Out in Trans Fat Lawsuit

FDA Regulation & Enforcement

Nov 18, 2019
OPDP Sends Untitled Letter Over Promotion of Investigational Drug
Nov 15, 2019
FDA Calls for Dollar Tree To Stop Distributing Drugs Made by Foreign Suppliers Cited for cGMP Violations
Nov 14, 2019
TGA Warns About Using ‘Stem Cells’ in Ads
Nov 14, 2019
Fagron Agrees To Pay $22.05 Million To Resolve Health Care Fraud Allegations Against Subsidiaries
Nov 14, 2019
Lawsuit Against Mississippi Vegan Meat Labeling Act Dropped After Regulatory Changes
Nov 12, 2019
French Physicians Not Receiving Company Gifts Prescribe Lower Cost Drugs
Nov 12, 2019
DOJ, OIG Detail Enforcement Plans
Nov 8, 2019
FTC Releases Influencer Disclosure Guidance
Nov 7, 2019
New FOP Calorie Labeling Regs for Food in Glass-Front Vending Machines Published
Nov 6, 2019
FDA Continues Policy of Enforcement Discretion for Food Co-Manufacturer Supply Chain Requirements

Medical Devices

Jul 17, 2013
FDA Calls for Feedback on Its Plan for Communicating Benefits, Risks of Devices
Jul 9, 2013
Draft Guidance Clarifies Device Reporting Mandates
Jul 5, 2013
CDRH Mulls Pilot Program for Pre-decisional IDE Review
Jun 26, 2013
FDA Proposes Updated Laser Products Performance Standard
Jun 17, 2013
Draft Guidance Addresses Device Cybersecurity
Jun 14, 2013
FDA Revises IDE Guidance To Meet FDASIA Provisions; Suggests Voluntary Pre-decisional IDE Process
Jun 14, 2013
How the Pre-decisional IDE Process Works
Jun 5, 2013
Stakeholders Criticize Draft Guidance on Device Recalls
May 23, 2013
CDRH Finalizes Guidance on Center Appeals Processes, Adds New 10.75 Review Requirements
May 16, 2013
Numbers of QS Inspections, Warning Letters Keep Increasing; CAPA, P&PC Issues Cited Most in 483s

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