FDA News: Week of December 5 and 12, 2016Voice


21st Century Cures Act: Making Progress on Shared Goals for Patients

By: Robert M. Califf, M.D., FDA Commissioner 

Robert Califf

President Obama signed into law the 21st Century Cures Act, on Dec 13th

  • Builds on FDA’s ongoing efforts to advance medical product innovation, quick patient access, assurance of high quality evidence of safety and effectiveness
  • Improves FDA’s ability to hire and retain scientific experts

Focus on:

  • Incorporation of patient’s voice into FDA’s decision-making
  • Modernizing and improving efficiency in clinical trial design
  • Effective FDA engagement for expediting product development and application reviews
  • New pathways for  antibacterials/antifungals, regenerative medicine products
  • Real world post market data for conducting more efficient research
  • Healthcare economic information to payers and formulary committees

READ


CDER PERFORMANCE

fda

CDER.JPG

Novel New Drug Approvals

  • Received 36 NME applications
  • Approved 19 NMEs*, including 7 Orphan Drugs

Reasons for fewer NMEs compared to CY15

  • Approval of 5 NMEs in CY15 with CY16 due dates
  • Fewer NME actions in CY16
  • Increased number of CR letters in CY16

Expedited Review

  • Priority Review : 68%
  • Breakthrough Therapy designation : 32%
  • Fast Track designation : 37%

Drug Innovation

  • Rare diseases : 37%
  • First in class : 37%
  • First approved in US : 84%

READ


CDRH PERFORMANCE

mdufa.JPG

pma.JPG

510k.JPG

de novo.JPG

  • Guidance Documents: 58
  • PMA: 89% approved
  • 510(k): 83% Substantially Equivalent
  • Direct De Novo: 30%
  • Pre-Submission Meetings: 939

Includes Division Level Data : DAGRID, DCD, DNPMD, DOD, DOED, DRGUD, DSD, DCTD, DIHD, DMD, DMGP, DRH

READ


Faster Information from FDA Means Improved Drug Safety for Patients

Mary E. Kremzner, PharmD, MPH, CAPT, U.S. Public Health Service, Director, Division of Drug Information, CDER

Mary KremznerEasy, FAST, Up-to-Date drug safety information for health care professionals and patients


The Mutual Reliance Initiative: A New Path for Pharmaceutical Inspections in Europe and Beyond

Dara Corrigan, J.D., Associate Commissioner for Global Regulatory Policy

Dara Corrigan

  • Concern: Rapid increase in imported drugs from nations with limited inspection resources e.g. China and India
  • Solution: FDA partnering with EU to rely on each other’s inspections, avoid duplication, conduct more inspections

Initiative: Mutual Reliance Initiative (MRI)

  • Launched in May 2014 -mutual recognition agreement
  • “Brexit” has no impact on FDA’s relationship with UK counterparts at this time
  • Key component covered in Transatlantic Trade and Investment Partnerships (T-TIP)

READ


Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s