Description

This webinar aims to bring understanding to ANDAs and Patent certifications.During the conference we will cover:

• Different requirements and regulations concerning production of generic drugs in relation to the original drug and brand name. This includes regulations for drugs with the same active molecule, same dosage, same technique and form of administration, and same usage conditions.
• The Hatch-Waxman Act, it’s intention and guidelines on FDA drug review and generic drug.The act covers also patent litigation for cases involving generic drugs.
• Filing for FDA approval for generic drug production using the two methods as stated by the Hatch-Waxman Act:1).An Abbreviated New Drug Application (ANDA); 2). 505(b)(2) Application. Under the Hatch-Waxman Act, there are certain market exclusivity periods for NDAs (non-patent based and patent based).
• The non-patent based New Chemical Entity (NCE) which allows a 5-year exclusivity to drug production, during this period firms can not file for ANDA. However, generic drug producing firms may file an ANDA with a Paragraph IV patent certification pursuant to the Hatch-Waxman Act, which allows them to directly challenge a brand name drug firm’s patent exclusivity for the RLD.
• By the end of this webinar conference, you should be able to understand different regulatory requirements for ANDA filings especially those concerning paragraph IV certifications.

Areas Covered in this Session :

• FDA Laws and Regulations
• Definition of notions
• The Hatch-Waxman Act
• Orange Book
• Regulatory Requirements for Generic ANDA and 505(b)2 Filings
• Patent-Based and Non-Patent Based Exclusivities
• Patent Certifications
• Paragraph IV Patent Certifications
• Reference Listed Drug (RLD)
• ANDAs with a Paragraph IV Certification
• Litigations and Patents

Who will benefit ?

• Firm CEOs
• Firm VPs
• Compliance Officers
• Attorneys at law
• Regulatory Affairs
• Clinical Affairs
• Quality Assurance
• Consultants
• People Interested in the FDA Drug Review and Approval Processes