FDA Biennial Registration Renewal 2014

All food facilities registered with FDA should complete their biennial  renewal before December 31st 2014

FDA Announces Medical Device User fee for FY 2015

                 

The annual establishment registration fee must be paid between October 1, 2014 and December 31, 2014. For FY15, the registration fee for each establishment is $3,646 

                                     FY15 User Fees (in U.S. Dollars)

application type	standard fee	small business fee
510(k)	$5,018	$2,509
513(g)	$3,387	$1,694
PMA, PDP, PMR, BLA	$250,895	$62,724
panel-track supplement	$188,171	$47,043
180-day supplement	$37,634	$9,409
real-time supplement	$17,563	$4,391
BLA efficacy supplement	$250,895	$62,724
annual report	$8,781	$2,195
30-day notice	$4,014	$2,007

FDA Activities are limited due to government shutdown

FDA activities are limited from October 1, 2013, and continuing until the date of enactment of  FY 2014 appropriation.

Drug Registration

Even though the activities are limited FDA is accepting SPL submission for Drug establishment registration, Drug listing and NDC Labeler code request. But the NDC Labeler code assignment may be delayed.

Food Facility Registration.

The food facility registration and prior notice modules are working fine during the lapse period

Medical Device Registration

FDA is not collecting the Establishment registration fee for the year 2014, which may affect the registration and listing of new medical device and renewal of existing registrations.

FDA is not accepting 2014 medical device user fees for regulatory submissions like 510 (k) for 2014 fiscal year which may affect the new submission to FDA.

FDA Biennial Registration Renewal

The extended time for FDA Biennial Registration Renewal will end by Jan 31, 2013. After that FDA may suspend the registration.

FDA announce Two-Week Grace Period for Generic Drug Facility Identification

FDA  announced a two-week grace period, until December 18, 2012, for Generic Drug Facilities that have not yet successfully completed the self-identification process.

The FY 2013 reporting period for facility self-identification closed on December 3, 2012.  Under the statute, generic drug products manufactured in facilities that have not self-identified, or including active ingredients manufactured in facilities that have not self-identified, are misbranded. 

source: fda

US FDA against illegal online pharmacies

The U.S. FDA  took action  against more than 4,100 Internet pharmacies that illegally sell potentially dangerous, unapproved drugs to consumers. Actions taken include civil and criminal charges, seizure of illegal products, and removal of offending websites.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm322492.htm

New FDA Medical Device Establishment Registration Requirements

FDA published the new requirements for Medical Device Establishments. As per the new requirements All medical device establishments - both domestic and foreign -  needs to pay FDA registration fee regardless of  activities conducted in the facility. the new fee for the year 2013 which starts from October 1st will be USD 2575.