Business briefs: FDA wants to relax Alzheimer's approvals rules, generics office head quits

Share this article:

FDA intends to loosen the rules for approving new Alzheimer's disease treatments, the agency said in a proposal that ran in the New England Journal of Medicine. The pathway to approval currently lies in studies which demonstrate both that patients have improved in their ability to think and remember as well as in daily activities like eating, washing and dressing themselves. The draft guidelines would expand drug approval criteria for those at early stages of the disease. Those with no apparent symptoms may now be studied with cognitive tests and those with mild symptoms can be studied via a combined test of function and cognition.

In other FDA news, the agency's Greg Geba announced he's stepping down as director of the Office of Generic Drugs ahead of a “realignment of the OGD's CMC functions and movement of the chemistry divisions into the proposed new Office of Pharmaceutical Quality” that “inevitably resets the scope of responsibilities and remit of our office.” He said the change, along with family needs, prompted the move and hailed the office's staff for issuing nearly 600 complete response letters and 200 ANDA approvals since the Generic Drug User Fee Act was implemented in October, thereby reducing the backlog of pending applications from 2,762 in September to 2,166.

Share this article:

Next Article in Business Briefs

Email Newsletters

More in Business Briefs

Imbruvica lassoes CLL indication

The FDA slapped a Breakthrough Therapy label on the CLL indication pursuit in February.

FDA asks social media "how'm I doin?"

The FDA's Center for Drug Evaluation and Research's Office of Communications wants a system that will help assess its messaging reach across the interwebs and its many forums.

Reckitt Benckiser wants out of pharma

The company plans to spin off its pharmaceutical unit.