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.

Clinical research agreements (CRAs) and developing a regulatory strategy—particularly in connection with the Food and Drug Administration ...

Fosamax further defines the obligation of drug manufacturers to present clear, unambiguous, and accurate information to the ...

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

Human safety requirements ... for approval, a justification for the difference should be included as part of the risk assessment. Additionally, when a (re)determination of microbiological ADI is ...

“Health Minute” brings original health care and health policy reporting from the KFF Health News newsroom to the airwaves each week. (3/18) Here's today's health policy haiku: ...

Objectives In an effort to mitigate COVID-19 related challenges for clinical research, the US Food and Drug Administration (FDA ... until there is either medical necessity or formalised regulatory ...

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

Opens in a new tab or window The FDA approved iptacopan (Fabhalta ... program requiring specific vaccinations. The drug may increase total cholesterol, LDL cholesterol, and serum triglycerides ...

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.