Category: Biopharma

Clinical Intelligence for better Clinical Trials

January 29, 2021
Biopharma

Every sector including healthcare is based on data nowadays. The only issue with healthcare is the complexity of the clinical data. The constant regulatory changes added with the rising competitions...

Clinical Intelligence, Clinical Intelligence in Clinical Trials, Role of Clinical Intelligence:

Regulatory Challenges for Combination Products

March 30, 2020
Biopharma

In the dynamic and ever changing global regulatory outlook, the area of combination products is an exciting expanse of attainable innovation and discovery for both the drug and medical device industries....

Drug Regulatory Authority of Pakistan (DRAP) Establishing Regulatory Pathway for Licensing System: A Progressive Approach

March 17, 2020
Biopharma

Drug Regulatory Authority of Pakistan (DRAP) implementing revised Licensing System, to ensure that all establishments comply with the Risk Based current Good Manufacturing Practices(GMPs) requirements...

USA: CDRH drafts Guidance on Contact Lenses – Performance Criteria to Support 510(k)s

March 17, 2020
Biopharma

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released new draft guidance to support firms planning to submit a 510(k) using the Safety and Performance...

FDA Drafts Guidance for Regulatory Submissions in Alternate Electronic Format

March 17, 2020
Biopharma

The US Food and Drug Administration (FDA) issued draft guidance providing recommendations on an alternate electronic format for submissions that qualify for an exemption or waiver from electronic common...

TMDA Released Guidance on the Import of Research Products to Be Used in Clinical Research

March 5, 2020
Biopharma

Turkish Medicines and Medical Devices Agency (TMMDA) issued guidance in order to determine the principles and procedures for the import of products to be used in clinical research studies conducted...