I attended the Annual GPhA meeting this past week. This event is attended by the CEO’s and other top brass of most of the major generic pharmaceutical companies. This year was highlighted by a presentation from the FDA Commissioner, Dr. Margaret Hamburg. In her remarks, Dr. Hamburg admitted to a need for FDA to step up [...]
Archive for the 'ANDA's' Category
Questions and Answers on the topic of Authorized Generics
Published December 21st, 2009 in ANDA's and How to:. 0 CommentsWhat would be the regulatory path for an Authorized generic, in general?
Authorized Generics (AG) are prescription drugs that are produced by the NDA holder and marketed under a private label, at generic prices. This circumstance typically presents itself when the NDA holder still has patent protection for the product on the market. Authorization of a [...]
ANDA Suitability Petition vs 505(b)(2)
Published June 12th, 2009 in 505(b)(2) Process and ANDA's. 0 CommentsI was honored to be invited to speak at the FDA-OCRA 12th Annual Educational Conference in Irvine California on June 10, 2009. I was asked to discuss and compare the 505(b)(2) and ANDA Suitability Petition. I thought I should share this topic with the readers of this blog.
Why make the comparison between an ANDA Suitability [...]
New MAPP for FDA Accepting Alternate Compendia for CMC standards
Published November 19th, 2007 in 505(b)(2) Issues and ANDA's. 0 CommentsOn 11/3/2007 FDA issued a new MAPP* entitled “Acceptability of Standards from Alternative Compendia (BP/EP/JP)”. Although directed at new drugs, one can probably argue that the policy should also apply to the Office of Generic Drugs. Up to now, reviewers seemed arbitrarily accepting or denying the use of BP, EP and JP grade excipients and [...]
Maybe the title should have a question mark after it - will the review time for a first generic drop? FDA plans to do so - it announced the Generic Initiative for Value and Efficiency (GIVE). Basically, the Office of Generic Drugs will try to review within 6 months an application for a first generic [...]
Can and Should ANDA Labeling Differ from the RLD?
Published February 11th, 2010 in ANDA's and News Commentary. 0 CommentsIn the past two months, two appellate courts, the Fifth Circuit and the Eighth Circuit have handed down decisions which essentially state that generic pharmaceutical companies can be sued in state courts for failure-to-warn regarding serious side effects, where the generic companies had conformed their labeling to that of the current Reference Listed Drug.
For a [...]