Nov 2 U.S. health regulators will delay
decisions on some drugs for up to two days because of the
massive storm Sandy, which closed the federal government.
The Food and Drug Administration said on Friday that the
delay in meeting regulatory timelines for prescription drugs,
medical devices and biosimilar drugs would apply to those with
target dates around Oct. 29 and 30, when offices were closed.
For those drugs with target dates on Oct. 31 or later, the
agency will consider whether a delay is warranted, but it will
not exceed two days.
Sandy hit the East Coast late on Monday. The U.S. government
closed ahead of the storm, and again on Tuesday due to
widespread power outages and transit issues.
The FDA has set times to review drugs under a user fee
program that manufacturers help fund in return for the agency's
meeting certain performance goals. For instance, it must review
a certain percentage of drug applications within a set time.
New drug application target approval dates under the
Prescription Drug User Fee Act, or PDUFA, are closely watched
because they indicate when companies will be able to start
selling their new products.
The Biosimilar User Fee Act - which applies to a new
generation of generic biotech treatments - and the Medical
Device User Fee Act also have approval schedules.
The FDA also said that applications submitted while it was
closed might have adjusted timelines.
(Reporting by Caroline Humer; Editing by Lisa Von Ahn)