Acting commissioner says greater flexibility in hiring has 'a real potential to solve some of our problems,' although only about 40-50 people have been added to date; recruitment and retention were very much on the minds of the FDA’s leadership at the recent BIO annual meeting, where center directors spoke of the long-term damage caused by the five-week partial government shutdown.

Feedback on application-specific data submission issues that vexed the agency but were not onerous enough to warrant a refuse-to-file letter would help inform future filings and reduce variation across sponsors, industry representatives say at meeting on analytical data standards.

Nathwani talks to Scrip about his unique dual role as chief medical officer and chief digital officer, Sanofi’s approach to digital therapeutics, and major hurdles to turning the promise of such technologies into a reality for patients.

Requiring that certain chemistry, manufacturing and controls conditions be satisfied before awarding breakthrough or regenerative medicine advanced therapy status would help ensure that the quality side of product development keeps pace with the clinical side, says Parexel's Mo Heidaran, a former CMC reviewer in the FDA’s biologics center.

Expect plenty of litigation over what constitutes infringement of a method-of-use patent even when the protected indication is not found on a biosimilar’s labeling, a panel of legal experts said at the recent BIO meeting; another area of unsettled law is the extent to which a biosimilar sponsor has satisfied the information-exchange provisions of the BPCIA ‘patent dance.’

The recent US FDA approval of three drugs – Alnylam’s Onpattro, Ionis’ Tegsedi and Pfizer’s tafamidis – in transthyretin-mediated amyloidosis means more opportunities to increase education and improve diagnosis in this rare disease, Alnylam CEO John Maraganore tells Scrip.