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FDA approval

February 1, 2014
Pharmaceutical Articles

21 CFR Part 11 – Code of Federal Regulations

The Title 21 Code of Federal Regulations Part 11 (21 CFR Part 11) provides compliance information regarding the U.S. Food and Drug Administration’s (FDA) guidelines on electronic records and electronic signatures. Within this part, requirements are created to help ensure security, integrity, and confidentially of electronic records and to ensure

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January 15, 2018

Expedite Reporting of Adverse Events: the Agency CFDA (China FDA)

Chinese pharmaceutical market is growing significantly and is going to be the

February 11, 2021

Samsung Biologics, National OncoVenture, and Eutilex obtains IND Approval from FDA

Samsung Biologics (KRX: 207940.KS) announced another successful Investigational New Drug (IND) clearance

CPhI Report forecasts explosion of contract services growth due to surging INDs and 75 FDA approvals by 2025
Pharmaceutical News

CPhI Report forecasts explosion of contract services growth due to surging INDs and 75 FDA approvals by 2025

March 10, 2021

A post-pandemic pharma report from CPhI predicts the next few years will deliver strong growth in pharma innovation, with oncology and rare

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Pharmaceutical News/Pharmacy

Samsung Biologics, National OncoVenture, and Eutilex obtains IND Approval from FDA

February 11, 2021

Samsung Biologics (KRX: 207940.KS) announced another successful Investigational New Drug (IND) clearance from the FDA for its client to begin

More
Pharmaceutical Articles

Expedite Reporting of Adverse Events: the Agency CFDA (China FDA)

January 15, 2018

Chinese pharmaceutical market is growing significantly and is going to be the world’s largest market within very few years. Many

More
Pharmaceutical Articles

21 CFR Part 11 – Code of Federal Regulations

February 1, 2014

The Title 21 Code of Federal Regulations Part 11 (21 CFR Part 11) provides compliance information regarding the U.S. Food and Drug Administration’s (FDA) guidelines

More
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