Acknowledgement Letter - Bivigam
Biotest Pharmaceuticals Corporation
Attention: Dr. Rainer Pabst
5800 Park of Commerce Blvd, NW
Boca Raton, FL 33487
Dear Dr. Pabst:
We have received your biologics license application (BLA) submitted under section 351 of the Public Health Service Act for the following biological product:
Our Submission Tracking Number (STN): BL 125389/0
Name of Biological Product: Immune Globulin Intravenous (Human):
Indication: Primary Immune Deficiency Disorders (PIDD)
Date of Application: November 3, 2010
Date of Receipt: November 3, 2010
Action Due Date: September 3, 2011:
US License Number and Manufacturing Site(s): 1792
All applications for new active ingredients, new dosage forms, new indications, new routes of administration, and new dosing regimens are required to contain an assessment of the safety and effectiveness of the product in pediatric patients unless this requirement is waived or deferred. We note that you have not fulfilled the requirements. We acknowledge receipt of your request for a waiver of pediatric studies in children less than 2 years of age and in children 2 to 5 years of age for this application. Once the application has been filed we will notify you whether we have waived the pediatric study requirement for this application.
Please note that you are also responsible for complying with the applicable provisions of sections 402(i) and (j) of the Public Health Service Act (PHS Act) (42 U.S.C. §§ 282(i) and (j), which was recently amended by Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Public Law No. 110-85, 121 Stat.904).
FDAAA amended the PHS Act by adding new section 402(j) (U.S.C. 282 (j)) which expanded the current database known as Clinical Trials.gov to include mandatory registration and reporting of results for applicable clinical trials of human drugs (including biological products) and devices. FDAAA requires that, at the time of submission of an application under sections 505, 515 or 520(m) of the FD&C Act (21 U.S.C. 355, 360e or 360j(m)), or under section 351 of the PHS Act (21 U.S.C. 262), or submission of a report under section 510(k) or the FD&C Act (21 U.S.C. 360(k)), such application or submission must be accompanied by a certification that all applicable requirements of 42 U.S.C. 282(j) have been met. Where available, such certification must include the appropriate National Clinical Trial (NCT) control numbers (42 U.S.C. 282(j)(5)(B)). You did not submit such certification when you submitted the BLA referenced in this letter. You may use Form FDA 3674, “Certification of Compliance, under 42 U.S.C. § 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank” to comply with the certification requirement.
In completing Form FDA 3674, you should review 42 U.S.C. 282(j) to determine whether the requirements of FDAAA apply to any clinical trials referenced in this application. Additional information on registering your clinical trials is available at the Protocol Registration System (PRS) Information Site http://prsinfo.clinicaltrials.gov/
We request that you submit all future correspondence, supporting data, or labeling relating to this application in triplicate, citing the above STN number. Send all correspondence to the following address:
Richard J. Davey, M.D., HFM-370
DCC, Suite 200N, HFM-99
Center for Biologics Evaluation and Research
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
Applicants who sent applications via the Food and Drug Administration Electronic Submissions Gateway (ESG) should continue to use those procedures. The ESG is an Agency-wide solution for accepting electronic regulatory submissions that enables the secure submission of regulatory information for review. Instructions for setting up an ESG account can be found at http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm
CBER strongly encourages the use of secure email. Secure email makes use of encryption during transmission and the messages are decrypted upon receipt using the certificate. To establish secure email, please follow the instructions in SOPP 8119: Use of Email for Regulatory Communications, Appendix 1 or Appendix 2.
CBER may communicate with you via non-secure email if you provide written authorization to do so. Authorization is file specific; please submit new authorization for each file and/or submission you hold with CBER.
Please note that CBER will only use email in place of telephone communications for general discussions, to relay regulatory issues and to request information. CBER will not provide copies of letters or meeting minutes by email and will not usually accept regulatory submissions via email.
We will notify you within 60 days of the receipt date if the application is sufficiently complete to permit a substantive review.
If you have any questions, please contact me at (301) 827-6124.
Pratibha Rana, M.S.
Regulatory Project Manager
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics
Evaluation and Research