In the pharmaceutical market FDA regulates prescription drugs in the USA:
- clinical trials
- FDA approval of a new drug
- collecting information about side effects
Permission FDA does not allow selling drugs without a prescription (OTS). At the same time, the ingredients for the FDA are undergoing the approval process for a new drug in the FDA..
FDA issues prior trade approvals:
- for medicines
- for biological products and reproduction of living organisms by gene transfer methods
- for cosmetics
- for the market trade of medicines for animals
- for medical devices
- for market trade in tobacco products
Final approvals are administered by the Federal Trade Commission.
FDA also approves ingredients for a non-prescription drug list (OTS). There are about 800 constituents, of which make about 100 thousand drugs. There is a list of acceptable ingredients for every non-prescription medicine, dose, wording, titles. In some cases, it includes the parameters of the necessary clinical trials.. Non-Prescription Medicines and Ingredients Do Not Require Additional FDA Approval. Authorization to sell a drug in the United States (without a prescription, off the counter) issued by the Federal Trade Commission, Federal Trade Commission.
The FDA gives the go-ahead for the safety of everything, what does the person use, including food and various devices, including through the FDA Center for Equipment Control and Radiation Safety (CDRH). This center gives permission for the market sale of household and professional items, controlling their production, use and safety. Devices are defined in the food law, medicines and cosmetics, and range from toothbrushes to brain stimulants. CDRH even regulates the trade in mobile phones and microwaves.
Clinical trials
U.S. Patent Application Filed Before Clinical Trials. For this reason, patents are effectively valid for 7-12 years.
Clinical trials of a drug begin after filing a patent application. Usually performed in laboratories in several states.
Medicinal substances, for which there is no marketing authorization, prohibited from exporting out of state. For this reason, trials can be started after the application for IND status has been applied., and not right away, and through 30 days, who will go to the FDA to check the status of the IND.
New Drug FDA Approval
Every new prescription drug in the United States must receive new drug status from the FDA..
For generics, ANDA is served. ANDA - application for FDA approval for the sale of generics, which is issued after proving the identity of its composition to a branded drug. Generics are brand name drugs with expired patents. US drug patents are valid for 20 years from the application for issuance.
For other drugs, an IND must be submitted before clinical trials. IND - Investigational Drug Status. Means, that the FDA is lifting the restriction on the export of substances, which is not authorized to sell, out of state.
NDA submitted after clinical trials – FDA marketing authorization application.
New drug status
Prior to marketing authorization, a substance must be a new drug., which is issued by the FDA. New drug "safe and effective, when it is used for its intended purpose ".
FDA Regulates Prescription Drugs. FDA approval does not allow the sale of drugs without a prescription.
Collecting information about side effects
Having received the status of a new drug (NDA), the sponsor reports all side effects to the FDA. Serious ones must be reported within 15 days, about the rest - during the quarter. The FDA is also looking at similar reports through an alternative channel - MedWatch.
FDA Approval for Trade in Tobacco Products
FDA approval to market tobacco products is required if, if the tobacco product was not marketed in the United States before February 2007 years and contains new tobacco substances. It takes up to 180 days.
If the product does not contain new tobacco substances, then the FDA for 90 days before the start of sales, you must submit a notification of the identity of the substances in one of two forms:
or about the identity of substances,
or on the exemption from the identity of substances (if the product contains more or less substance, than in its already sold counterpart).
FDA Approval for the Trade in Cosmetics
Cosmetics are also considered drugs and must be approved by the FDA., if it affects the structure or functional characteristics of the processed tissue. Permits for cosmetics are issued by the Center for Food Safety and Practical Nutrition.
In addition, the FDA controls, so that insufficiently tested products do not hit the shelves without warning on the packaging about the possibility of side effects.
FDA Approval for Trade in Animal Products
FDA Veterinary Medicine Center Issues Food Permits, food additives and medicines for animals other than vaccines, whose market is regulated by the Ministry of Agriculture.
NADA is issued for medicines, ANADA and CNADA.
NADA is an analogue of NDA when obtaining a permit for medicines for animals.
ANADA - analogue of ANDA when obtaining a permit for medicines for animals.
CNADA - Application for Conditional Approval, which is issued until then, until full NADA approval for a new drug is received due to a shortage of (from the FDA and the drug manufacturer) evidence of drug efficacy.
FDA Approval for Medical Devices
PMA is issued for medical instruments, 510(k) и HDE.
PMA is an analogue of NDA when obtaining permission to sell medical instruments.
510(k) - analogue of ANDA upon obtaining permission to sell medical instruments.
HDE - analogue of CNADA upon obtaining permission to sell medical instruments, allowed for tools, on which the treatment depends no more 4000 US residents per year.
