Generics With Poor Bioavailability May Not Use 505(b)(2) "Paper" NDA
Generic drug applicants may not use the paper NDA 505(b)(2) mechanism of approval for products that have a reduced rate of absorption compared to the innovator, FDA said in its "Guidance for Industry: Applications Covered by Section 505(b)(2)."
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
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