Case Review Form

      * Denotes required field.

      Title

      * First Name

      * Last Name

      * Email Address

      * Phone Number

      Cell Phone Number

      Office Phone Number

      Street Address

      Apartment/Suite

      City

      State

      Zip Code

      Please provide the best method and times to contact you:

      Date of birth of injured person
      (mm-dd-yyyy):

      Name of drug:

      Date you started taking the drug (mm-yyyy):

      Date you stopped taking the drug (mm-yyyy):

      Please describe any side effects:

      Other Info:

      No Yes, I agree to the Parker & Waichman LLP disclaimers.Click here to review all.

      Yes, I would like to receive the Parker & Waichman LLP monthly newsletter, InjuryAlert.

      please do not fill out the field below.

FDA Changes Drug Application Response Letters

Filed July 10th, 2008 amy

The FDA announced Wednesday that the agency, as of August 11, 2008, will be revising its rejection letters to companies. Rather than issuing boilerplate “approvable” or “not approprovable” letters for drug applications, the FDA will begin to issue what it calls a “complete response” letter at the end of the review period to let a drug company know of the agency’s decision on the application.

“These new regulations will help the FDA adopt a more consistent and neutral way of conveying information to a company when we cannot approve a drug application in its present form,” said Janet Woodcock, M.D., director of the agency’s Center for Drug Evaluation and Research (CDER). “Thorough and timely review of drug applications is a priority of the FDA, and these new processes will make our communications with sponsors of applications more consistent.”

Taking the place of “approvable” and “not approvable” letters, a “complete response” letter will be issued to let a company know that the review period for a drug is complete and that the application is not yet ready for approval. The letter will describe specific deficiencies and, when possible, will outline recommended actions the applicant might take to get the application ready for approval.

Currently, when assessing new drug applications, the FDA can respond to a sponsor in one of three types of letters: an “approval” letter, meaning the drug has met agency standards for safety and efficacy and the drug can be marketed for sale in the United States; an “approvable” letter, which generally indicates that the drug can probably be approved at a later date provided that the applicant provides certain additional information or makes specified changes (such as to labeling); or a “not approvable” letter, meaning the application has deficiencies generally requiring the submission of substantial additional data before the application can be approved.

The revision should not affect the overall time it takes the FDA to review new or generic drug applications or biologic license applications. These changes are not expected to directly affect consumers.

Be Sociable, Share!

Comments are closed.

Click Here Now, to Have an Attorney Answer Your
Medicinal Drug Injuries Questions
No Cost - No Obligation!