Vulnerable population (a) Description of the vulnerable population. (b) Description o ...

information about any report of suspected unexpected serious adverse event occurring ...

7.2.2 Review of requirements related to the product: The manufacturer shall review th ...

The Drugs & Cosmetics Act, 1940 and rules 1945 have entrusted various responsibilitie ...

Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of New Drugs, Co ...

Drugs and Cosmetics Act, CDSCO is responsible for approval of New Drugs, Conduct of C ...

Ethics Committee This section shall document that the clinical investigation was cond ...

(d) records needed to provide evidence that the realisation processes and resulting p ...