Lachman CONSULTANTS - Bob Pollock先生 2015-02-11
编译：识林-椒 2015-02-11
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Snippets from the GPhA Annual Meeting Technical Committee Meeting
Written by Bob Pollock • February 11, 2015
The GPhA Annual Meeting is being held in Miami this year. I'm sorry that I had to miss it (first time in over 20 years!) but the change in meeting dates conflicted with an already planned family trip. But the good news is that we are wired into some of the happenings behind the scenes and I have this to report.
FDA is finally rolling out its Target Action Date (TAD) program for all pre-year three applications. This is something that is being done now for the year three GDUFA cohort and will give pre-year three applicants at least a hint of when they might expect to see a Complete Response Letter (CRL). Look for a TAD soon for those ANDAs,as the FDA said they hope to have this well underway by the end of the first quarter of the calendar year 2015.
In another move, FDA will also be sending out launch planning updates 3-6 months before TADs for “big” generics. While we are not quite certain as to the definition of “launch planning updates”, it sounds like FDA recognizes the need to have a lead time for the applicant to prepare for launch as the product approaches the approval stage, as opposed to having the applicant being surprised by an Approval Letter that arrives out of the blue and unexpectedly.
The FDA will also begin iterative real time communications for deficiencies in the current review cycle. Hopefully, it will allow the review to continue and the applicant to respond bringing the application to approval in that cycle without the need to issue a CRL, to reach minor amendment status in that cycle, or to give the applicant early feedback on application issues .
Another bit of info that I heard was that FDA said that it does not expect its approval times to improve at least for the next two years. Unfortunately, there is no surprise there!
