Under the second iteration of the Generic Drug User Fee Act (GDUFA II), the US Food and Drug Administration (FDA) has agreed to provide timely abbreviated new drug application (ANDA) review status updates for all pending ANDAs. The updates for applicants on their ANDA review status will include the issuance of Information Requests (IRs) and Discipline Review Letters (DRLs), and to provide applicants with an advance notification of regulatory correspondence, includ...

Thanks to the new Generic Drug User Fee Act (GDUFA II), the US Food and Drug Administration (FDA) this week launched a new online platform to allow industry to request pre-ANDA (abbreviated new drug application) meetings for complex generic drugs.  The CDER Direct NextGen Collaboration Portal allows potential ANDA applicants to initiate requests by uploading a meeting request package and to submit supporting documents, such as meeting presentation materials, re...

The US Food and Drug Administration (FDA) has approved more abbreviated new drug application (ANDA) in 2017 than any other year, according to the latest FY 2017 activities report. The 763 approvals (or 927 approvals and tentative approvals) is 112 more generic approvals than last year , which set the previous record for the highest tally in a year, and 271 more than 2015 and 354 more than in 2014 . And unlike in 2016, when FDA issued a vastly higher number of ...

Jeff Shuren, director of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) told attendees at the final session at AdvaMed’s MedTech conference in San Jose, California, that his center is plotting the creation of a new "super office." The so-called "Total Product Life Cycle 'Super' Office" will integrate premarket, postmarket surveillance and quality-compliance functions, Shuren said, noting it will be "a big deal." The o...

A little more than 10 months into Fiscal Year 2017 and the US Food and Drug Administration (FDA) is on pace to break its record for abbreviated new drug application (ANDA) approvals from last year. According to the latest version of the activities report of the generic drug program , FDA has approved 633 generic drugs in FY 2017, which compares with a total of 651 approvals in FY 2016 . Also a positive: complete responses for generic drugs are down significantl...

May and June 2017 have seen the most generic drug approvals since the US Food and Drug Administration (FDA) began tallying its monthly approvals, lending credence to FDA Commissioner Scott Gottlieb's pledge to speed approvals and lower drug costs. According to the activities report of the generic drug program , FDA approved and tentatively approved 96 generic drugs in May and 100 in June (a level FDA has not seen since December 2015 when 99 generics were approved and...

In preparation of its commitments under the second Generic Drug User Fee Amendments (GDUFA II) , the US Food and Drug Administration (FDA) on Monday released a draft guidance laying out how sponsors can qualify for shorter review times for priority generic drugs. Under GDUFA II, FDA agreed to shorten its review of eligible priority generics by two months if sponsors submit a complete and accurate pre-submission facility correspondence (PFC) two months ahead of their a...

The US Food and Drug Administration (FDA) on Tuesday granted accelerated approval to Merck’s Keytruda (pembrolizumab) for patients whose cancers have a specific biomarker. FDA noted in a statement : "This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated." Keytruda, an anti-PD-1 therapy that has been approved to treat a variety of cancers dating back to 2014 ...

The US Food and Drug Administration (FDA) on Friday authorized the use of a first-of-its-kind medical device to treat infants up to one year old for a rare birth defect that causes a gap in the esophagus. The device, Cook Medical’s Flourish Pediatric Esophageal Atresia Anastomosis, was authorized via the humanitarian device exemption (HDE) process as an estimated 1 in every 2,500 babies in the US is born with the condition, known as esophageal atresia. "This new...

With a focus on how the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) can further use real-world evidence to inform its decision making, the center is considering "progressive" approvals whereby if a device comes to market in the EU before the US, it could also come to market in the US as long as additional postmarket data is submitted. Jeff Shuren, director of CDRH, speaking by teleconference at the MedCon conference in ...

The US Food and Drug Administration (FDA) is poised to make a comeback from the relatively low number of new drugs approved in 2016, though it's unlikely to match the approval highs from 2014 and 2015. Already in 2017, FDA has approved 14 new drugs , though that quick pace is not likely to continue and the rest of the year is shaping up to be an average or slightly above average year for approvals. Based on data from BioPharmCatalyst , FDA has just over 20 remaining a...

The biggest outstanding challenge for the generic drug industry moving into the second iteration of its user fee agreement is multiple cycle reviews before approval, Kathleen Uhl, director of the US Food and Drug Administration’s (FDA) Office of Generic Drugs told participants Tuesday at a generic drugs forum for small businesses. According to FDA’s latest complete set of data, only 9% of abbreviated new drug applications (ANDAs) won approval in the first review cycle, ...