Department of Health and Human Services March 8, 2010 – Federal Register Recent Federal Regulation Documents
Results 1 - 16 of 16
New Animal Drug Applications; Confirmation of Effective Date
The Food and Drug Administration (FDA) is confirming the effective date of March 8, 2010, for the final rule that appeared in the Federal Register of October 23, 2009 (74 FR 54749). The direct final rule amends the regulations regarding new animal drug applications (NADAs). Specifically, this direct final rule is being issued to provide that NADAs shall be submitted in the described form, as appropriate for the particular submission. Currently, the regulation requires that all NADAs contain the same informational sections and does not explicitly provide the appropriate flexibility needed to
International Conference on Harmonisation; Guidance on S9 Nonclinical Evaluation for Anticancer Pharmaceuticals; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``S9 Nonclinical Evaluation for Anticancer Pharmaceuticals.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides recommendations for nonclinical studies for the development of pharmaceuticals, including both drugs and biotechnology derived products, intended to treat patients with advanced cancer. The recommendations describe the type and timing of nonclinical studies to support an investigational new drug application (IND) and the submission of a new drug application (NDA) or biologics license application (BLA). The guidance is intended to provide information on internationally accepted recommendations for nonclinical studies to facilitate the development of anticancer pharmaceuticals.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
