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Questions Email, July 13, 2011 - Anascorp


From: Jennifer Spinella [jspinella@raretx.com]
Sent: Wednesday, July 13, 2011 1:04 PM
To: Fisher, Robert
Cc: Cordaro, Debbie
Subject: RE: Questions regarding Anascorp lot release and samples

Hi Robert,

Thank you for the explanation.  It is very helpful. We have requested the permit to import/export from Mexico to the US the samples from lot (b)(4).  We will not submit samples from the transfer lots and will not sell these in the US. 

Jennifer

 


From: Fisher, Robert [mailto:Robert.Fisher@fda.hhs.gov]
Sent: Wednesday, July 13, 2011 9:07 AM
To: Jennifer Spinella
Cc: Cordaro, Debbie
Subject: RE: Questions regarding Anascorp lot release and samples

 

Hi Jennifer.  I hope this clears up any confusion.  Please note that we have reconsidered and are NOT requesting samples or protocols for the technology transfer lots at this time.  If you have any questions, please feel free to email or call either myself or Debbie.

 

  Your conformance lots are used to demonstrate your compliance with cGMP regulations, and we are basing your license on lot (b)(4), as well as the two lots manufactured during your 2011 prelicensure inspection.  The Office of Compliance and Biologics Quality has determined that since Anascorp technology transfer lots ----------(b)(4)------------- were manufactured prior to the three conformance lots, they may not be released to the U.S. market. Since these lots will not be released for the U.S. market, you are not required to submit samples or protocols for lots -----------(b)(4)-------------.

  We will the approve release of the one conformance lot that is ready at the same time that we approve the BLA. However, we will need to receive lot-release protocols in advance for this lot, and will issue the release concurrently with sending the approval letter. The additional two conformance lots, and all future lots produced, will also need to be submitted for release.

  More generally, for a drug product approved for sale and distribution in the US:

  Every lot of the drug product must be released by CBER in advance of its being distributed for sale in the US. This involves the submission to CBER, by the drug manufacturer, of lot-release protocols and product samples. CBER then reviews the submitted data and may test the samples, prior to release. The release itself is done via a written notification by CBER to the manufacturer. The drug-product lot must not be distributed in the US until notification of lot release is obtained.

  The regulatory authority for this requirement is given in the Code of Federal Regulations 21 CFR 610.2.

  



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From: Jennifer Spinella [mailto:jspinella@raretx.com]
Sent: Monday, July 11, 2011 18:41
To: Fisher, Robert
Cc: Cordaro, Debbie
Subject: RE: Questions regarding Anascorp lot release and samples

Hi Robert,

Yes, we will submit these samples along with the samples from lot (b)(4) of the conformance lot.  The other conformance lots will be submitted once they are completed.  Do we need to wait to hear back from FDA regarding their release, or once we are approved we can sell?  Please clarify.

Thanks,

Jennifer

 


From: Fisher, Robert [mailto:Robert.Fisher@fda.hhs.gov]
Sent: Monday, July 11, 2011 3:33 PM
To: Jennifer Spinella
Cc: Cordaro, Debbie
Subject: Re: Questions regarding Anascorp lot release and samples

 

Hi Jennifer. In that case, in addition to the released conformance lot can you submit samples of the three tech transfer lots as well as their lot release protocols? We'd also expect samples and lot release protocols for the other two conformance lots when available.
Robert W. Fisher, Ph.D.
Staff Fellow
FDA/CBER/OBRR/DH/LPD
301-496-2579
Robert.Fisher@fda.hhs.gov
 


From: Jennifer Spinella [mailto:jspinella@raretx.com]
Sent: Monday, July 11, 2011 05:33 PM
To: Fisher, Robert
Cc: Cordaro, Debbie
Subject: RE: Questions regarding Anascorp lot release and samples
 

Yes, that was the plan.

Jennifer

 


From: Fisher, Robert [mailto:Robert.Fisher@fda.hhs.gov]
Sent: Monday, July 11, 2011 1:01 PM
To: Jennifer Spinella
Cc: Cordaro, Debbie
Subject: RE: Questions regarding Anascorp lot release and samples

 

I have a question about Anascorp lots -----------(b)(4)-------------. I believe these were your technology transfer lots, and were manufactured at full scale.  Are these lots intended for release to the U.S. market if your license application is approved?

 

Thanks,

Robert 

 



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From: Jennifer Spinella [mailto:jspinella@raretx.com]
Sent: Monday, July 11, 2011 15:32
To: Fisher, Robert
Cc: Cordaro, Debbie
Subject: RE: Questions regarding Anascorp lot release and samples

Thanks Robert!  We appreciate your help.

Jennifer

 


From: Fisher, Robert [mailto:Robert.Fisher@fda.hhs.gov]
Sent: Monday, July 11, 2011 12:31 PM
To: Jennifer Spinella
Cc: Cordaro, Debbie
Subject: RE: Questions regarding Anascorp lot release and samples

 

Hi Jennifer. Yes, you can disregard the section on (b)(4). 

 

I'm working on a response to your question regarding the conformance lots. 

 

Best,

Robert

 



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From: Jennifer Spinella [mailto:jspinella@raretx.com]
Sent: Monday, July 11, 2011 15:22
To: Fisher, Robert
Cc: Cordaro, Debbie; -----------(b)(4)-------------
Subject: Questions regarding Anascorp lot release and samples
Importance: High

Dear Dr. Fisher,

 

Thank you for sending us the template for submitting our Anascorp lot release data.  The template includes (b)(4) testing.  We do not perform this test because we perform the rabbit pyrogen test instead.  Can we state the (b)(4) is not applicable or can we disregard this information and not include it?  We only test our final product using the rabbit pyrogen test. 

 

Also, regarding the samples that have been requested, two of the conformance lots are not complete at this time.  They will not be complete until August 1 (Lot (b)(4)) and August 22 (lot (b)(4)).  Can we only submit samples at this time for lot (b)(4)?  We are requesting the permit from the Mexican Health Authorities for the exportation of the Anascorp samples.  This could take at least a week.  Will this be a problem?

 

Thank you for your assistance.

Jennifer

 

Jennifer Spinella, MT(ASCP), RAC

Vice President, Regulatory Affairs & Quality Assurance

Rare Disease Therapeutics, Inc.

9550 Cuyamaca Street, Suite 203

Santee, CA 92071

Phone:  619-328-5370

Fax:  619-328-5379

email:  jspinella@raretx.com