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

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

XTalks

DECEMBER 9, 2024

The US Food and Drug Administration (FDA) has released a new draft guidance titled Expedited Program for Serious Conditions Accelerated Approval of Drugs and Biologics Guidance for Industry refining the accelerated approval pathway for drugs and biologics targeting serious or life-threatening conditions.

Clinical Trials 105

Clinical Trials Clinical Trials Compliance Trials 105

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

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

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

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