Does US need another expedited development pathway? Groups weigh in
This article was originally published in SRA
US regulators have had a mixed response to a new pathway they have proposed for expediting the development of medicines intended to treat serious or life-threatening conditions with unmet medical needs. Under the pathway, the Food and Drug Administration would permit manufacturers to take a streamlined approach with shorter studies using smaller patient populations1,2.
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.