Will accelerated approval, antibiotic add-ons bog down PDUFA?
This article was originally published in Scrip
In what looked like an attempt to pack as many topics as possible into one hearing, members of the House Energy & Commerce Health Subcommittee on 8 March heard advice over nearly four hours from an array of witnesses on a hodgepodge of proposals that lawmakers are seeking to bundle into the legislation reauthorizing the US FDA's user fee programme.
You may also be interested in...
With new funding in hand, Moderna and its infectious disease venture Valera are going full-speed ahead with a Zika vaccine, taking an mRNA approach, which they said could be a more rapid strategy to try to stop the disease.
Allergan CEO Brent Saunders vows not to engage in price gouging and says his firm will limit cost increases to single-digit percentages, occurring only once per year. But it's unclear whether Saunders will stand as a lone wolf in the industry or if others will make similar pledges.
Hillary Clinton's plan to rein in high prices of older medicines, which includes creating a federal panel that has authority to impose fines, may grab headlines, but some analysts think it's unlikely to get very far in a divided Washington.