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Libby Laboratories, Inc. – 708259 – June 27, 2025: Insights and Developments
07/08/2025
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PHARMACEUTICALS & BIOTECH
Regulatory Intelligence
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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
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De Novo NRA Classification
New Market Authorization Class I
New Market Authorization Class II
New Market Authorization Class III
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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
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FOOD SUPPLEMENTS, COSMETICS, DISINFECTANTS & FMCG
Regulatory Intelligence
Intellectual Property Rights Protection
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Authorized Representative
NRA Classification
Cosmetics MA
Food Supplements MA
Disinfectants MA
Commercial Ad, Labeling andClaims Compliance Check
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