Generic Drugs
A generic drug is identical -- or bioequivalent -- to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price.
According to the Congressional Budget Office, generic drugs save consumers an estimated $8 to $10 billion a year at retail pharmacies. Even more billions are saved when hospitals use generics.
Featured Products
Best Practices in Quality and Compliance Management
Price: $70.00
Price: $70.00
Generic Drug Product Development (ANDA) and Paragraph IV Filing Strategy (Exclusive to the US Market)
Strategic Planning for an ANDA- Communication with the FDA - ANDA content and format - FDA-sponsor meetings planning and handling - CMC data expectation - bioequivalence/ bioavailability
Strategic Planning for an ANDA- Communication with the FDA - ANDA content and format - FDA-sponsor meetings planning and handling - CMC data expectation - bioequivalence/ bioavailability
Drug Master Files (DMF's) - Understanding and Meeting Your Regulatory and Processing Responsibilities
Drug Master File (DMF) Submission - FDA requirements - NDA - ANDA - IND - Export Application - Processing and Review - Transfer of Ownership - DMF closure
Drug Master File (DMF) Submission - FDA requirements - NDA - ANDA - IND - Export Application - Processing and Review - Transfer of Ownership - DMF closure
Practical Strategies to a successful 505(b)(2) product
505(B)(2) regulation and guidance from the FDA - strategic considerations - challenges - solutions - future trends
505(B)(2) regulation and guidance from the FDA - strategic considerations - challenges - solutions - future trends