What does FDA mean in the Philippines?
What does FDA mean in the Philippines?
Food and Drug Administration (Philippines)
| Agency overview | |
|---|---|
| Parent department | Department of Health |
| Website | www.fda.gov.ph |
How do I contact FDA Philippines?
Contact Us
- (02) 8857-1900. local 1000.
- (02) 8842-5635.
How do you contact the FDA?
Contact FDA
- Call: 1-888-INFO-FDA. (1-888-463-6332)
- Email: See Contact FDA Centers and Offices below or search the employee directory.
- Write to: Food and Drug Administration. 10903 New Hampshire Ave. Silver Spring, MD 20993-0002.
What does FDA stand for?
The Food and Drug Administration
Español. The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services.
Who needs FDA approval Philippines?
The Food and Drug Administration (FDA) regulates certain products in the Philippines. These include food, medical and pharmaceutical products, and cosmetics. A company dealing in these products needs an FDA certificate for product registration.
What does FDA approved mean?
FDA Approval: What it means. FDA approval of a drug means that data on the drug’s effects have been reviewed by CDER, and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population.
How do I file a complaint with the FDA in the Philippines?
You may also report on-line at www.fda.gov.ph: tab “eReport” or please email directly at [email protected]. 4.8. For complaints involving Adverse Drug Reaction (ADR), please accomplish on- line ADR Form at www.fda.gov.ph: tab “ADR Report”. 4.9.
What does FDA approve?
The FDA approves new human drugs and biological products. This means that a company must demonstrate that its drug or biological product is safe and effective for the intended use, and that it can manufacture the product to federal quality standards.
Who do I contact at FDA for a recall?
Call 1-888-INFO-FDA (1-888-463-6332 ).
How do I get FDA approval in the Philippines?
How to Get an FDA Certificate of Product Registration in the Philippines
- Application form.
- Valid license to operate from the FDA.
- Product labels. You must provide copies of the product’s labels in all packaging sizes.
- Product documents.
- Certificate of analysis.
- Product sample.
What FDA approved means?
How do I report something to the FDA?
You can report a problem to the FDA online, via phone, or via mail. For emergencies: Call 9-1-1 immediately. In limited emergency situations (which are urgent but not life-threatening), you or your health care professional can report problems to the FDA’s emergency line at 1-866-300-4374 or 301-796-8240.
How much does it cost to get FDA approval in the Philippines?
Fees to be Paid : AO No. 50 s. 2001 Branded: PHP 10,000.00 + 1% LRF Unbranded: PHP 7,500.00 + 1% LRF Additional (if with variation/s) Payment shall be based on FDA Circular No.