Type AType B / Type B (EOP)Type DINTERACT and INTERACT “lite”Formal and informal meetings with OOPDPre-Sub (Q-sub)ANDA product development and pre-submissionInformal meetings
Archives: FAQs
Regulatory Assets
Breakthrough Designation Fast Track Designation Orphan Designation Rare Diseases Voucher Special Protocol Assessment Tropical Diseases Voucher Small Business Designation
Dosage Form Experience
CapsulesCreamsGelsLiposomesMedical GasesMicrodose PowdersMonoclonal AntibodiesParenterals (liquid lyophilized)Parenterals (powder fill)OverencapsulationPatchesPowdersSynthetic and Semi-synthetic Drug SubstancesTablets (IR and E...
Therapeutic Area Experience
AllergyCardiovascular/RenalDermatologyDiagnostic and Therapeutic RadiopharmaceuticalsGIImmunologyInfectious DiseaseNeurologyOncologyOphthalmologyPainPsychedelicsPsychiatryReproductive HealthUltra Rare Diseases
Application Type Experience
505(b)(1) 505(b)(2) 505(j) – ANDA Medical Device Combination Products IND IDE DMF Orphan Breakthrough Rare Pediatric Disease Rare Tropical Disease Small Business
gET sOCIAL