Industry news

FDA Update: Janet Woodcock CDER, at recent FDLI event in DC

FDA CDER Director Janet Woodcock shared her views on the 3 ‘big ticket’ items currently engaging FDA at the FDLI Conference in Washington, DC on April 23rd. Janet indicated that her ‘big 3’ were:

• Implementation of FDASIA (Food and Drug Safety and Innovation Act)
• Biosimilars
• CDER’s new Drug Quality Initiative

FDASIA has 150 specific requirements for FDA, including 19 Regulations, 24 Guidances, and 14 reports to Congress. GDUFA aims to bring down the review cycle for Generic Drugs to a 10 month review cycle by year 5. The new OGD ‘Super’ Office will move to the White Oak campus next year.

FDA are also working towards standardizing approaches for drugs requiring REMS programs of monitoring.

In the Biosimilars area, FDA is currently dealing with 55 requests related to 12 reference products. 16 are at the IND phase.

CDER’s Quality Initiative is moving forward internally after the formation of the Council of Pharmaceutical Quality two years ago.

FDA believe that further modernization to the regulation of Drug Quality and Surveillance is needed. FDASIA gives them the required authority and resources.

FDA will be seeking a more level playing field and standards for drugs from all sources - R&D, Generic, and OTC. As part of this, FDA are also looking at the use of standard metrics for measuring manufacturing qualilty.