Posts Tagged ‘Guidance’

After Six Years FDA Finalizes Guidance on Assessing Abuse Potential of Drugs

After Six Years FDA Finalizes Guidance on Assessing Abuse Potential of Drugs

After 6 years US FDA finalized Guidance on Assessing Abuse Potential of Drugs on 18th January 2017. The first draft was prepared almost six years back, this guidance seems to help sponsors of investigational new drugs in analyzing whether their new drug has abuse potential.

More particularly, US FDA states that the guidance provides suggestions for evaluating the abuse potential of central…

FDA Final Guidance on Microbial Vectors Used for Gene Therapy

FDA Final Guidance on Microbial Vectors Used for Gene Therapy

The US FDA’s Center for Biologics Evaluation and Research, recently released final guidance for  the investigational new drug (IND) submissions for microbial vectors used for gene therapies (MVGTs) in early phase clinical studies.

The 27 page final guidance comes after a draft released in October last year and is used to supplement: “Guidance for FDA Reviewers and Sponsors: Content and Review of…

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