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FDA Introduces Innovative Review Tool for Sarepta’s Gene Therapy Developments
06/04/2025
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PHARMACEUTICALS & BIOTECH
Regulatory Intelligence
Intellectual Property Rights Protection
Regulatory Compliance and Gap Analysis
Pre-Sub Activities
Authorized Representative
NRA Classification
Investigational New Drug (IND) Application
Innovative Drug MA (Novel NDA)
Generic Drug (ANDA) New MA
Type IA and IA-IN variation notifications
Type IB variation notifications
Type II variation approval
Line (MA) Extension
MA Renewal
Ongoing Pharmacovigilance Service
Commercial Ad, Labeling and Health Claims Compliance Check
Randomized Labeling for CRO
Non-clinical data SEND conversion
CARES Act Reporting
REMS and ETASU Development
Sunset Clause and MA closing activity
Medical Devices & IVD
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MEDICAL DEVICES & IVD
Regulatory Intelligence
Intellectual Property Rights Protection
Regulatory Compliance and Gap Analysis
Q-Sub Activities
Authorized Representative
De Novo NRA Classification
New Market Authorization Class I
New Market Authorization Class II
New Market Authorization Class III
New Market Authorization Class I-IV
Pre-market Notification 510(k)
Premarket Approval (PMA)
The Breakthrough Devices Program
MA Renewal
Medical Device Recall
Commercial Ad, Labeling and Health Claims Compliance Check
Randomized Labeling for CRO
Single Lay User Prototype UI/UX Testing
Sunset Clause and MA closing activity
Other Healthcare Products
Toggle child menu
Expand
FOOD SUPPLEMENTS, COSMETICS, DISINFECTANTS & FMCG
Regulatory Intelligence
Intellectual Property Rights Protection
Regulatory Compliance and Gap Analysis
Pre-Sub Activities
Authorized Representative
NRA Classification
Cosmetics MA
Food Supplements MA
Disinfectants MA
Commercial Ad, Labeling andClaims Compliance Check
Updates
Toggle child menu
Expand
GDP Matrix
4 Entities Matrix
News & Updates
Contact Us
