All News | FDA

Advertising & Promotion

Oct 20, 2014
CMS Expands Open Payments Review Options with Simplified Search for Consumers
Oct 16, 2014
Bill Looks To Circumvent CMS Rule Mandating Disclosure of Medical Texts
Oct 13, 2014
CBER Untitled Letter Blasts Company for Promoting Specialty Biologic as a Combination Drug/Biologic
Oct 3, 2014
CMS Launches Open Payments Database, Millions of Records are Partial or Omitted
Sep 29, 2014
OPDP: E-Submission System Expected To Be Operational by Next Spring
Sep 26, 2014
OPDP Warning Letter Accuses Pacira of Promoting Drug for Unapproved Uses
Sep 26, 2014
FDA Gives Industry 30 More Days To Comment on Social Media Drafts
Sep 25, 2014
Shire To Pay $56.5 Million Over FCA Claims of Off-Label Promotion, Unproven Statements
Sep 24, 2014
OPDP’s First Enforcement Letter in Months Targets Superiority Claims in Mass Email
Sep 18, 2014
Fitness Company To Shell Out $3 Million in FTC Settlement Over Violative Infomercials

Good Clinical Practice

May 23, 2016
Common Rule NPRM Draws Nearly 2,200 Comments; Biospecimens Are Biggest Concern
May 23, 2016
FDA Reissues 2007 COPD Draft Guidance, Wants Comment on Subject Survey
May 20, 2016
ACRP Starts ‘Onboarding’ Program To Train CRAs
May 17, 2016
EHRs Used in Trials Don’t Have To Be Part 11 Compliant, But Still Must Be Valid and Reliable
May 17, 2016
CTTI Issues Recommendations for DMC Best Practices
May 12, 2016
ACRO Urges FDA To Back New Trial Technologies
May 12, 2016
ACRO Says FDA Can Be “Very Helpful” in Getting Wearable Technology into Clinical Trial Use
May 11, 2016
FDA Calls Workshop on Clinical Trial Designs for Antimalarial Drugs
May 11, 2016
U.S. Senate Bill Looks To Protect State ‘Right-to-Try’ Laws from Federal Meddling
May 4, 2016
Senators Urge NIH To Improve Data Collection on Children in Clinical Trials

FDA Regulation & Enforcement

Feb 4, 2019
Federal Appeals Court Reverses Summary Judgment Favoring Company in Off-label Marketing Case
Feb 1, 2019
Amended Complaint Provides More Detail for Massachusetts Lawsuit Against Purdue Pharma
Jan 31, 2019
Agency Guidance Cannot Be Used To Prove Statutory or Regulatory Violations, DOJ Policy Manual Says
Jan 31, 2019
Small Study Finds Cost Mitigation Disclosures Lessen Price Shock in DTC Drug Ads
Jan 29, 2019
Petition Seeks Ban on Certifying Hydroponic Products as Organic
Jan 29, 2019
NAD Upholds Some Claims for Abbott Milk Fortifier, Recommends Changes for Others
Jan 24, 2019
Survey Finds Most Physicians Would Not Allow Off-label Promotion
Jan 23, 2019
Grassley, Klobuchar Introduce Bill To Allow Individuals to Import Prescription Drugs From Canada
Jan 23, 2019
Firm Recalls Chicken Products Due to Undeclared Allergen
Jan 23, 2019
DePuy Reaches $120 Million Consent Judgment with States

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