The integration of AI and cloud technologies is transforming pharmaceutical manufacturing regulations, focusing on safety, efficiency, and global harmonization.

This approval allows Enable to deliver its innovative solutions throughout the EU. “The CE Mark is a significant milestone in our regulatory ... with the drug product requirements.

U.S. Food and Drug Administration states that data from the ongoing OnPrime/GOG-3076 Phase 3 registrational trial could potentially support ...

Cancer drugs with higher clinical benefit in ... Investigators evaluated factors at accelerated approval including regulatory pathways, pivotal trial characteristics, safety data, confirmatory ...

1,477 drug regulators from the CDSCO and states have been trained on various drug regulatory aspects focused on improving their skills, knowledge, inspections, investigations and review of dossiers.

Some U.S. health regulators who review medical devices and tobacco products for safety and efficacy are struggling to meet ...

MANILA, Philippines — Top Line Business Development Corp. has obtained final regulatory approval for its maiden share sale, paving the way for the country’s first initial public offering (IPO ...

Investing.com -- Tesla (NASDAQ:TSLA) announced on Monday that it plans to introduce its smart driving-assistance feature in China, following the completion of regulatory approval. This comes after ...

The Parliamentary Panel on Chemicals and Fertilisers has recommended to the Department of Pharmaceuticals (DoP) to strengthen penalties under the regulations against manufacture and sale of ...

BEIJING (Reuters) -Tesla (TSLA)said on Monday it would release its smart driving-assistance feature in China after completing regulatory approval, following complaints that a limited-time free ...

A group of senators this week reintroduced a bill titled “The Interagency Patent Coordination and Improvement Act,” which ...

Drug development programs face unique challenges in demonstrating the safety and effectiveness of drugs for treating rare diseases. The ...