FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss
FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss
Industry Resources
Information to assist the drug manufacturing industry in the development of generic drugs and the completion of abbreviated new drug…
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Applications and following the path to generic drug approval. Generic drug applications are termed “abbreviated” because they…
2024 NCTR Research Highlights
2024 NCTR Research Highlights and Accomplishments:
ProRx, LLC – 696742 – 03/04/2025
Compounding Pharmacy/Adulterated Drug Products
Safe Chain Solutions, LLC – 636044 – 03/10/2025
Drug Product/Adulterated
Safe Chain Solutions, LLC – 636044 – 06/08/2023
Drug Product/Adulterated
CDER – Biological Product Deviations
CDER – Biological Product Deviations
La FDA advierte que los medios de contraste basados en gadolinio (MCBG) se depositan en el cuerpo y exige una nueva clase de advertencias
La FDA advierte que los medios de contraste basados en gadolinio (MCBG) se depositan en el cuerpo y exige una…
FDA Drug Safety Communication: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings
FDA is requiring a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance…