What is a suitability petition FDA?
A suitability petition is a request by a drug sponsor (called the “petitioner”) to submit an abbreviated new animal drug application (ANADA) for a proposed generic new animal drug that differs from the reference listed new animal drug (RLNAD).
What are the examples of changes to approved drug products for which 505 b )( 2 application should be submitted?
Examples of products eligible for the 505(b)(2) approval process include but are not limited to the following:
- Change in the route of administration.
- Conversion to lower or higher strength.
- Change in the route of administration of dosage form or dosage regimen.
- Change in the formulation.
How do I petition FDA?
Petitions can be sent electronicially to FDA via www.regulations.gov at http://www.regulations.gov/#!documentDetail;D=FDA-2013-S-0610-0001 or must be mailed or delivered to the Division of Dockets Management, Food and Drug Administration, Room 1061, 5630 Fishers Lane, Rockville, MD 20852.
What is the 30-month stay?
This 30-month postponement, commonly referred to as the “30-month stay,” gives the brand product sponsor and patent holder a prescribed amount of time to assert patent rights in court before a generic competitor is approved and can market the drug.
How are bioequivalence studies conducted?
Bioequivalence studies can be conducted in a non-replicated or replicated fashion. The standard two-period, two-formulation, two-sequence crossover study uses a non-replicated design. In terms of statistical analysis criteria, therefore, an average bioequivalence approach is generally sufficient.
What is the 505 B 2 pathway?
The 505 (b)(2) pathway provides manufacturers who have certain types of drugs with an opportunity to acquire FDA approval without performing all the work that’s required with an NDA. These drugs are not strictly generics, but are often not entirely novel new molecular entities either.
How long does ANDA approval take?
Next GDUFA However, under the next iteration of GDUFA, which will take effect in FY2018, ANDA standard review time will likely be 10 months from submission and priority review would be eight months from submission. This is compared to the 42- to 44-month average approval time before GDUFA was in place.
What is a CDRH petition?
A petition is a way for individuals, regulated industry or consumer groups to petition the agency to issue, change or cancel a regulation, or to take other action.