Assembler’s Guide to Diagnostic X-Ray Equipment Guidance for Industry and Food and Drug Administration Staff
Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA Guidance for Industry
“Medical X-Ray Imaging Devices Conformance with IEC Standards Guidance for Industry and Food and Drug Administration Staff”
“Q13 Continuous Manufacturing of Drug Substances and Drug Products Guidance for Industry”
“Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment Guidance for Industry”
Q13 Continuous Manufacturing of Drug Substances and Drug Products Guidance for Industry
Drug or Device – Who regulates your product?
The very first step towards bringing your product to the market is understanding which center at the FDA shall regulate your product. The primary centers at the FDA are: CDRH – Center for Devices and Radiological Health CDER – Center for Drug Evaluation and Research CBER – Center for Biologics Evaluation and Research Although, FDA … Read more Drug or Device – Who regulates your product?
INTRODUCTION Nutraceuticals is a broad umbrella term that is used to describe any product derived from food sources with extra health benefits in addition to the basic nutritional value found in foods. The term “nutraceutical” combines two words – “Nutrient” (a nourishing food component) and “pharmaceutical” (a medical drug). The name was coined in 1989 … Read more Nutraceuticals