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Sep 6, 2018
Sanofi To Pay $25 Million To Settle SEC Case
Aug 31, 2018
District Court Allows Insurance Fraud Case Against Insys To Proceed
Aug 29, 2018
Pfizer Requests FDA Guidance on Biosimilar Communications
Aug 29, 2018
Canadian Province Sues Opioid Makers
Aug 28, 2018
OPDP Releases Fourth Untitled Letter for 2018
Aug 27, 2018
Two Senators Question Giuliani Involvement in DOJ-DEA Investigations of Purdue Pharma
Aug 24, 2018
NAD Refers Cold Sore Claim to FDA and FTC
Aug 24, 2018
Senate Adds DTC Price Listing Amendment To HHS Appropriations Bill
Aug 23, 2018
Companies Battle Before NAD Over ‘Dry Mouth’ and ‘Saliva Substitute’ Products
Aug 22, 2018
District Court Allows Lawsuit Questioning Whether a 510(k) Device Can Be Advertised as FDA-Approved

Good Clinical Practice

Nov 8, 2018
Better Guidelines Needed for Including Pregnant Women in Clinical Trials
Nov 8, 2018
FDA Issues Final Guidance for Developing Combo Approved Drugs for Hypertension
Nov 7, 2018
FDA Issues Guidance on Meta-analysis for Safety Concerns
Nov 7, 2018
FDA Posts MyStudies App Links
Nov 6, 2018
Cancer Groups Release Recommendations for Immune-Oncology Trial Reporting
Nov 5, 2018
Trial Database Launched
Nov 5, 2018
Senators Urge NIH to Update Guidance on Minority Group Inclusion in Clinical Trials
Nov 1, 2018
FDA Issues Guidance on Trials To Assess Drug Testicular Toxicity Risks
Nov 1, 2018
FDA Releases Draft Guidance on Using MRD as Trial Biomarker
Nov 1, 2018
ACRP To Develop Principal Investigator Competence Standards

U.S. Food Labeling

Nov 12,2014
AMS Final Rule Paves Way for Fee Formula
Nov 5,2014
GMO Labeling Measure in Oregon Poised for Defeat in Close Election
Nov 5,2014
Colorado’s GMO Labeling Ballot Initiative Goes Down in Flames
Oct 30,2014
FDA Says the Most Common Cause for Allergen-based Recalls Is Mislabeling
Oct 28,2014
USDA Guidance Outlines Procedures for Making Non-GMO Labeling Claims on Organic Foods
Oct 24,2014
FDA Must Develop Final GRAS Rule Before September 2016 Under Consent Decree
Oct 22,2014
WTO Panel: COOL Rule Changes Violate International Trade Accords
Oct 20,2014
Perdue Farms Drops ‘Humanely Raised’ Claims Under a Settlement with the Humane Society
Oct 18,2014
Vt. Unveils Proposed Rules for GMO Labeling
Oct 15,2014
Cash Pours in for Proponents, Opponents of Oregon’s GMO Food Labeling Measure

FDA Regulation & Enforcement

Dec 9, 2021
Allergan Settles with New York over Opioid Marketing
Dec 9, 2021
FDA Is Asking for Input on Use of NAC as Dietary Supplement
Dec 8, 2021
Trade Group Asks Court To Bar FDA from Asserting that Dietary Supplement Is an Unapproved Drug
Dec 3, 2021
OIG Opinion OKs Sponsor Picking Up Medicare Beneficiary Costs in Clinical Trial
Dec 2, 2021
DOJ: French Citizen Made False Statements to FDA To Fraudulently Obtain Control of Weight Loss Drug
Dec 1, 2021
OIG Will Not Sanction Drug Maker’s Arrangement with Hospitals
Nov 23, 2021
FDA Conducted Twice the Number of Domestic Inspections It Had Projected for Fiscal Year 2021
Nov 22, 2021
DOJ: Orthopedic Device Development Royalties Dispute with Surgeon Evolved into Illegal Kickback Scheme
Nov 21, 2021
Meeting Archive Available on Toxic Elements in Baby Food
Nov 21, 2021
Recordings From Food E-Commerce Summit Available

Medical Devices

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