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Avoiding Common Pitfalls: Tips for Complying with FDA Cosmetics Regulations

Cosmetics

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), cosmetics are defined by their intended use—products applied to the human body for cleansing, beautifying, enhancing attractiveness, or...

Compliance Tips, Cosmetics Compliance, Cosmetics Regulations, FDA Compliance, FDA Regulations

Pharma Regulatory Intelligence Tools and Supply Chain Management

Biopharma

Many Organizations are relaying on the Regulatory Intelligence databases due to burden of collecting, understanding, interpretation of data from the regular authorities. Regulatory Intelligence tools...

Pharma/Biotech – USA, Europe Regulatory News, July 2023 Vol. 1

Biopharma

USA CMS IRA Updates Bring No Significant Strategic Shift for Manufacturers Despite ongoing lawsuits and thousands of public comments, CMS has made limited adjustments to the drug price negotiation...

Biotech Regulatory News, EMA, EU Regulatory News, FDA, GCP Guideline, MHRA, Pharma Regulatory News, Regulatory News, RWD, RWE, USA Regulatory News

What Pharma Companies need to know about EU MDR Regulations?

Biopharma

EU MDR The Medical Device Regulation (MDR), which was adopted in April 2017, changes the European legal framework for medical devices The EU MDR entered into application on 26 May 2021 REGULATION...

Compliance, EU MDR, Medical Device Regulations, Pharmaceutical Industry, Regulatory Affairs

Pharma/Biotech – USA, Europe Regulatory News, June 2023 Vol. 1

Biopharma

USA The FDA Issues Development Program Guidance’s to Assist Drug, Device Sponsors The The The FDA issued multiple guidance document’s on Friday to help sponsors conduct drug-drug interaction...

Biotech Regulatory News, EU Regulatory News, European Medicines Agency, Pharma Regulatory News, Regulatory News, US FDA, USA Regulatory News

Pharma/Biotech – USA, Europe Regulatory News, May 2023 Vol. 1

Biopharma

USA FDA Requests Feedback on Proposed Consumer Prescription Advertising Survey The FDA’s Office of Prescription Drug Promotion (OPDP) is inviting public comments on its plan to study how consumers...