zuloonine.blogg.se - American conference

#American conference trial
#American conference license

Factoring expedited programs into your drug development strategy.Assessing the breakthrough therapy, regenerative medicine advance therapy (RMAT), and fast track designation programs.Understanding accelerated approval, surrogate and intermediate clinical endpoints.Evaluating the criteria for eligibility, benefits, and limitations of each program.Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.ĭistinguishing among the different FDA programs for expedited review and approval of drug products Understanding How FDARA and the 21st Century Cures Act are impacting drug approvals through new evidentiary requirements.OTC Monograph Drug User Fee Program (OMUFA).Differences between approved and monographed OTC drug products.Examining the OTC Review and monographs.Understanding the concept of “OTC” (OTC-ness).Distinguishing complex molecules regulated through NDAs from from small molecules.Identifying applications for fixed-dose combination drugs.Exploring key similarities and differences between the drug and biological product schemes.How do the research, development, and approval process for biological products differ from the process for new drugs?.

#American conference license

Deciphering the biologics license application (BLA).

What are biological products in relation to traditional drugs?.

Dissecting the investigational new drug application (IND) vs.

Examining the research, development, and approval process for new drugs.

Understanding the difference between “new drugs” and other drugs.

Making sense of PDUFA Goals, fast track, break through status, and other process enhancements.

Reviewing the fundamentals of applications from submission, through filing and beyond.

Innovator Products: New Drug Applications and Biologic License Applications Kleinfeld, Kaplan & Becker, LLP (Washington, DC) Understanding the Scope of FDA Enforcement Authority and Actions Preparing for the Worse: Adverse Events Monitoring, Pharmacovigilance, Risk Management, and Recalls Part 2 Exploring the Subtleties and Safe Zones of Off-Label Communications Part 1 – Drug and Biologics Advertising and Promotion 101 IP Overview for Drugs and Biologics Part 2 – Hatch-Waxman and BPCIA Fundamentals: Understanding Follow-On Products and the Rules for Generic Entryĭrugs and Biologics Labeling: Appreciating the Importance of the Final Step of the Approval ProcessĬGMPs: Discovering the Unique Role of Current Good Manufacturing Practices (“cGMPs”) in the Post approval ProcessĪdvertising, Promotions, and Related First Amendment Concerns: IP Overview for Drugs and Biologics Part 1 – Patents and Related IP Protections and Mechanisms

#American conference trial

THE PRE-APPROVAL AND APPROVAL PROCESS Navigating the Approval Process for Drugs and BiologicsĮxploring FDA’s Expedited Programs: Applicability and EligibilityĪppreciating the Nuances of the Approval Process for Controlled SubstancesĬlarifying the Clinical Trial Process for Drugs and Biologics Amin Talati Wasserman LLP (Washington, DC) Day 1 - Wednesday, Septem8:15