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What are complex pharmaceutical products?

What is a complex generic drug product? A product with: ... Complex drug-device combination products (e.g., auto injectors, metered dose inhalers); and. Other products where complexity or uncertainty concerning the approval pathway or possible alternative approaches would benefit from early scientific engagement.

What are the phases for FDA approval?

Information For Step 1: Discovery and Development. Step 2: Preclinical Research. Step 3: Clinical Research. Step 4: FDA Drug Review. Step 5: FDA Post-Market Drug Safety Monitoring.

How does the FDA monitor?

The FDA does perform lot release testing of many biological products, which provides the agency with a real-time system to continuously monitor product quality, through review and testing. For more information, see: A directory of approved and unapproved finished drugs on the market.

When do companies announce FDA approval?

The FDA has 60 days to decide if the application is acceptable for review. If accepted, the FDA then has 10 months to respond (or 6 months for a priority review) with an approval or non-approval or with a 'complete response'.

What are the 5 phases of FDA approval?

A pharmaceutical company seeking FDA approval to sell a new prescription drug must complete a five-step process: discovery/concept, preclinical research, clinical research, FDA review and FDA post-market safety monitoring.

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