A positive step towards Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices!! Draft guidance.

On September 21, 2016 FDA issued a Draft guidance to assist Drug Sponsor and Device Manufacturer to encourage coordination in development of Antimicrobial Drugs and Antimicrobial Susceptibility Test (AST) devices so that AST device can be cleared at the time of NDA or shortly after that.

AST is an important component in development of new antimicrobial drugs, clinical testing and identifying emergence of drug resistance. The coordinated development will benefit both the Drug sponsor and Device manufacturer by having access to each others data and information as also potentially minimizing the time between approval of drug and device. Both the parties involved can submit their coordinated development plan to both CDER and CDRH for review and comments. The Device manufacturer can request for a joint meeting between, Drug Sponsor, Device Manufacturer, CDER and CDRH under the pre-submission process to discuss about the AST device and coordinated plan.

Through the Draft Guidance, FDA intends to accomplish the following

• Describe interactions between drug sponsors and device manufacturers for coordinated development of a new antimicrobial drug and an AST device;
• Explain the considerations for submitting separate applications to CDER and CDRH when seeking clearance of an AST device coincident with, or soon following, antimicrobial drug approval
• Clarify that the review of the new antimicrobial drug product and AST device(s) will remain independent, and that coordinated development does not influence the MDUFA and PDUFA review timelines for either product.

Electronic or written comments on the guidance have to be submitted by November 21, 2016

• Submit electronic comments in the following way:
  Federal eRulemaking Portal. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, will be posted to the docket unchanged
• Submit written/paper submissions as follows:
  Mail/Hand delivery/Courier (for written/paper submissions):
  Division of Dockets Management (HFA-305),
  Food and Drug Administration,
  5630 Fishers Lane, Rm. 1061,
  Rockville, MD 20852.
• Confidential Submissions
  To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on regulations.gov.

IFor more information on the guidance please visit Draft Guidance for Industry and Food An Drug Administration Staff
Federal Register

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