NUMBER OF ANDA APPLICATIONS REQUIRED FOR CERTAIN VARIATIONS
Executive Summary
NUMBER OF ANDA APPLICATIONS REQUIRED FOR CERTAIN VARIATIONS of solid oral and injectable dosage forms will be reduced to a single ANDA or AADA (abbreviated antibiotic drug application) under a May 25 interim "Policy and Procedure Guide" issued by FDA's Division of Generic Drugs. The guide points out that "applicants have been required to submit separate ANDAs or AADAs for each drug dosage form and also for each variation of that dosage form." This requirement has "multiplied the paperwork submitted by industry and has multiplied the number of documents that FDA must review, act upon, and archive," the guide notes. The new policy has been developed to "reduce the burden." The revised policy "only applies to tablets, capsules and injectable dosage forms. The policy is unchanged for other dosage forms," the guide emphasizes. Charts included with the interim guide explain which variations are eligible to be included in a single application. The division will begin accepting new original applications that consolidate variations into a single application as of Oct. 1. Between Oct. 1 and Dec. 31, "consolidation will be an option," but as of Jan. 1, 1991 "it will be required," the guide says.
You may also be interested in...
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
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 Skin Infections Guidance Spurs Debate On Endpoint Relevance
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
Shire Hopes To Sow Future Deals With $50M Venture Fund
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