Description:-

• The regulatory rule 505(b)2 allows the Food and Drug Administration of the United States, also known as the FDA to control and approve the development of small molecule drugs and other biological agents.
• Under the 505(b)2 regulation, applicants can submit to the FDA for approval, any new drug in development, various formulations of drugs, drug dosage and administration form, new combinations of drug and biological agents that have already been approved and more.
• In general, 505(b)2 allows an applicant to depend on the safety data of a product that has been approved already.
• To be more specific about this regulation, an application made under rule 505(b)2 should contain one or more investigations and research not conducted by the applicant or conducted for the applicant and for which the applicant has not been awarded the right to reference the data by the person who conducted the investigation or by the person the investigation was conducted for.
• For biological agents, the regulation offers a narrow category of bio agents for marketing approval. Biological products approved under the 505(b)2 regulation are also considered approved under the 351(k) regulation once the 10year phase-in period is over, this is in accordance with the Affordable Care Act (ACA).
• This webinar conference aims to help the industry gain better understanding of the regulation pathway 505(b)2 so it can be used to get FDA approval of drugs and biological agents.
• The speaker will cover everything under regulation 505(b)2 and walk through FDA’s recommended practices for drug and biologics approval.

Area covered in the session :

• Definitions
• Statutes and regulations
• Misconceptions
• Categories Approvable under 505(b)2
• 505(b)2 approval requirements
• 505(b)2 Applications
• CMC Requirements under 505(b)2
• Examples of drugs and biologics approved under 505(b)2
• Injectable Biologics Approved under 505(b)2
• Best Practices recommendations according to PASS-IT

Who will benefit :

• CEOs and VPs
• Compliance Officers
• Attorneys
• Regulatory Affairs
• Clinical Affairs
• Quality Assurance
• Research and Development
• Consultants
• Anyone Interested in the FDA Drug Review and Approval Processes