ProRelix Research

DECEMBER 28, 2023

Considering the crucial role that the information generated from clinical trials play in the approval of new drugs, biological, and medical devices, it is only logical that the data garnered […] The post Clinical Data Standardization in Clinical Trials: FDA Compliance in Clinical Data Management appeared first on ProRelix Research.

FDA Compliance 52

FDA Compliance Clinical Trials Clinical Trials Compliance 52

Pharma Mirror

JANUARY 5, 2024

New Delhi, India – FD-AID, LLC, a distinguished leader in pharmaceutical quality and compliance solutions, proudly announces its entry into the Indian pharmaceutical market.

Compliance 130

Compliance FDA Compliance Marketing Drugs 130

XTalks

DECEMBER 9, 2024

Notably, the FDA can now mandate that confirmatory trials begin before approval, ensuring proactive validation of clinical benefits. The draft also formalizes withdrawal procedures for non-compliance, including delayed studies or failure to confirm benefits.

Clinical Trials 105

Clinical Trials Clinical Trials Compliance Trials 105

Cloudbyz

AUGUST 19, 2024

Food and Drug Administration (FDA), the European Medicines Agency (EMA), and various other national and international organizations oversee the approval, monitoring, and post-market surveillance of medical devices. Compliance with their regulations is mandatory for manufacturers seeking to market their devices globally.

Compliance 52

Compliance Manufacturing Regulation Marketing 52

Intouch Solutions

NOVEMBER 18, 2021

And educational resources have been created detailing the RSA ad format to share with the audiences who review creative assets for FDA compliance. All newly created ad plans and ad plan updates will heavily feature the RSA ad format.

Branding 52

Branding FDA Compliance Marketing Regulation 52

Pharma Marketing Network

OCTOBER 24, 2024

However, with the rise of digital marketing, compliance has become more complex. Always be one step ahead by integrating compliance checks into every campaign and staying informed on FDA and EMA guidelines. The trick is balancing engagement with compliance.

Marketing 52

Marketing Branding Pharma Companies Compliance 52

FDA Law Blog

JANUARY 1, 2024

The FDA compliance data, sorted by category, shows there were 159 Warning Letters issued to drug manufacturers or sponsors during 2023, with 161 issued in calendar year 2022. Summaries of the most striking recently released Warning Letters are included below.

Manufacturing 59

Manufacturing Production Drugs Contract Manufacturing 59