- Settore: Government
- Number of terms: 2516
- Number of blossaries: 0
- Company Profile:
The FDA is responsible for pprotecting the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products, medical devices, the US food supply, cosmetics, dietary supplements, and products that give off radiation.
Хирургическа процедура за повдигане на гърдата и намаляване на увисването и. Жените могат също да се подложат на тази процедура след отстраняване на имплант.
Industry:Beauty
Rijetka, ali po život opasna infekcija koja se može pojaviti nakon operacije. Simptomi su iznenadna groznica, povraćanje, proljev, nesvjestica, vrtoglavica i osip sličan opeklinama od Sunca. Ukoliko se posumnja na sindrom toksičnog šoka, treba se odmah javiti liječniku radi dijagonosticiranja i liječenja.
Industry:Beauty
An abbreviated new drug application (ANDA) contains data that, when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Generic drug applications are called "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, a generic applicant must scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the innovator drug). Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public.
Industry:Pharmaceutical
This six-digit number is assigned by FDA staff to each application for approval to market a generic drug in the United States.
Industry:Pharmaceutical
An active ingredient is any component that provides pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or animals.
Industry:Pharmaceutical
The approval history is a chronological list of all FDA actions involving one drug product having a particular FDA Application number (NDA). There are over 50 kinds of approval actions including changes in the labeling, a new route of administration, and a new patient population for a drug product.
Industry:Pharmaceutical
An official communication from FDA to a new drug application (NDA) sponsor that allows the commercial marketing of the product.
Industry:Pharmaceutical
Biological products are approved for marketing under the provisions of the Public Health Service (PHS) Act. The Act requires a firm who manufactures a biologic for sale in interstate commerce to hold a license for the product. A biologics license application is a submission that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product. If the information provided meets FDA requirements, the application is approved and a license is issued allowing the firm to market the product.
Industry:Pharmaceutical
