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 Compliance Clinical Trials Clinical Trials 52

Pharma Mirror

JANUARY 5, 2024

Spearheaded by a former US FDA Investigator and seasoned pharmaceutical executive, FD-AID is uniquely positioned to bring a wealth of expertise and insight to India’s rapidly growing pharmaceutical industry.

Compliance 130

Compliance FDA Compliance Marketing Drugs 130

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

The trick is balancing engagement with compliance. How do you market a new diabetes drug like Trulicity or Ozempic while maintaining FDA compliance? Channels like Facebook , LinkedIn , and Twitter offer direct access to both healthcare professionals and patients.

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 57

Manufacturing Production Drugs Contract Manufacturing 57

Cloudbyz

AUGUST 19, 2024

Strategies include: Compliance with Local Regulations: Adapting labeling to meet the specific requirements of each market, including language translations, symbols, and regulatory information. For example, the EU requires CE marking and compliance with the MDR, while the U.S. requires FDA compliance and UDI labeling.

Compliance 52

Compliance Manufacturing Regulation Marketing 52

FDA Law Blog

JUNE 9, 2021

Koblitz — While typically, FDA is responsible for setting forth its own agenda and enforcing compliance with its own regulations, the Trump Administration’s HHS, on its way out the door in late 2020 , took the unusual steps of withdrawing an important FDA Compliance Policy Guide, “Marketed Unapproved Drugs – Compliance Policy Guide Sec.

Compliance 52

Compliance Drugs Production Marketing 52