IND SUBMISSIONS MAY INCLUDE UNAUDITED INTEGRATED TOX SUMMARY -- FDA REFORMS; CLINICAL HOLD AUTHORITY LIMITED TO NEW DRUG REVIEW DIVISION DIRECTORS
Sponsors would be allowed to use unaudited, integrated toxicology summaries in support of an IND submission for a drug or "well-characterized" biologic under one of three FDA reform proposals related to INDs. In a Nov. 21 "Talk Paper," the agency said it is issuing a guidance "which signals FDA's willingness to accept a summary report of toxicology findings based upon unaudited, draft toxicologic reports of completed studies."
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth