View all newsletters
Receive our newsletter - data, insights and analysis delivered to you

A Brief Summary of Seven Different 505(b)(2) Approvals

According to the guidance, a 505(b)(2) application is one for which one or more of the investigations relied upon by the applicant for approval ‘were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted’ (21 U.S.C. 355(b)(2))’.

In other words, one of the primary advantages of submitting a 505(b)(2) is the potential of getting a drug approved based on studies already in the scientific literature, as opposed to repeating clinical trials.

PDG has compiled a brief summary of seven different 505(b)(2) approvals, including notable features and a tabular overview of each. Many generic companies are turning toward more complex dosage forms, 505(b)(2) development, and even biosimilars to hedge the increasingly overcrowded traditional markets.

The paper provides a variety of everyday issues to consider as you contemplate your next development project.

Click here to read more.

Clinical trial consulting and pharmaceutical consulting professionals will benefit by becoming current on adaptive trial design.
Safety surveillance and pharmacovigilance consulting to generic drug manufacturers, as well as generic drug labelling consulting may soon become a service in demand.
Pharmaceutical Development Group (PDG) is a drug and medical device consultant that continuously engages in meetings and interactions with the US Food and Drug Administration...
NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. A weekly roundup of the latest news and analysis, sent every Friday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy


Thank you for subscribing to Pharmaceutical Technology