Newsletter | February 13, 2023

02.13.23 -- The Power Of Using The 505(b)(2) Pathway

Addressing 505(b)(2) Product Development Challenges Before They Become Problems

Many 505(b)(2) development programs have been placed on clinical hold or otherwise disrupted because of incorrect or inadequate advice from professionals inexperienced in 505(b)(2) product development. Gain insight on how to rectify past missteps and avoid future ones in three program examples.

Improving NDA Approval Odds For New Dosage Forms Of Approved Products

There are numerous reasons why a sponsor may wish to market a new dosage form of an approved product. Aside from the financial benefits to the sponsor, learn why providing a more convenient and/or faster-acting dosage form of a well-chosen drug provides significant benefits for patients.

Using The 505(b)(2) Pathway To Streamline Approval Of Combination Products

In recent years, the quantity of approvals for products and 505(b)(2) applications has risen. By using a streamlined NDA process, developers can reduce the size and/or scope of the nonclinical and/or clinical program for eligible combination products.

The 505(b)(2) Pathway: Getting To The Clinic Faster

Discover the advantages of the 505(b)(2) pathway, look at common misconceptions, and get practical advice on its application in the real world.

Aligning For 505(b)(2) Success: Oncology Combination Product First-In-Class Treatment Success

Throughout the life cycle of a drug development program, sponsors are confronted with a range of key questions. Discover why beginning with the end in mind means having the right regulatory and commercial plan in place early.