List Headline Image
Updated by Ravinder Singh on Jul 27, 2019
 REPORT
2 items   1 followers   2 votes   0 views

Clinical Trails

Veeda Clinical Research is one of the best clinical trials CRO in India offering clinical trial phases & development programs from small to mid-size & global pharma companies. We offer comprehensive services including clinical trials study, clinical trials research, and therapeutic confirmatory studies.

1

FDA Publishes Guidance for Inactive Ingredient Database

FDA Publishes Guidance for Inactive Ingredient Database

The FDA has released draft guidance for using the Inactive Ingredients Database to aid drug developers.

The US Food and Drug Administration (FDA) has released draft guidance for public consultation on the use of the Inactive Ingredient Database (IID).

2

Proposed Rule Designed to Open Biosimilar Competition

Proposed Rule Designed to Open Biosimilar Competition

In an effort designed to ensure adequate supplies and to stimulate biosimilars competition, FDA has proposed a new rule that would clarify the use of information contained in drug master files (DMFs) for certain biologics (i.e., hormones and enzymes previously licensed under the Food, Drug and Cosmetics Act [FD&C Act] that will transition to licensing under the Public Health Service [PHS Act] on March 23, 2020).

Currently, FDA does not allow licensed biologics applications to reference DMFs for information on drug substances or intermediates.