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5c1c13d314e1ca84500ed18a9ad19b200afacfd39b9587ddcc941a0d0a450b2a
What is the number written above TAK-INDNDA-01577086? Give a very brief answer.
425.
docvqa
5c1c13d314e1ca84500ed18a9ad19b200afacfd39b9587ddcc941a0d0a450b2a
What is the contact number of Ms. Jena Weber, Regulatory Project Manager? Ensure brevity in your answer.
301-827-6422.
docvqa
5c1c13d314e1ca84500ed18a9ad19b200afacfd39b9587ddcc941a0d0a450b2a
What is the full form of ODE? Give a very brief answer.
Office of Drug Evaluation.
docvqa
5c1c13d314e1ca84500ed18a9ad19b200afacfd39b9587ddcc941a0d0a450b2a
What is written above Page 2 on the top? Keep it short and to the point.
IND 33, 729.
docvqa
3b817505b6b719598950d2a33ab77016a4ff7ef76a599751c368718e74f70b89
What is the unit mentioned in the letter ? Provide a succinct answer.
7200.
docvqa
3b817505b6b719598950d2a33ab77016a4ff7ef76a599751c368718e74f70b89
What is the date mentioned Your response must be concise.
9/23/93.
docvqa
3b817505b6b719598950d2a33ab77016a4ff7ef76a599751c368718e74f70b89
Name of the first person in the To list? Offer a very short reply.
Pj daniels.
docvqa
3b817505b6b719598950d2a33ab77016a4ff7ef76a599751c368718e74f70b89
From whose desk this letter is written ? Offer a terse response.
Timothy j gumbleton.
docvqa
3b817505b6b719598950d2a33ab77016a4ff7ef76a599751c368718e74f70b89
Whose letter's copy is attached? Your response must be concise.
DR. Mitchell.
docvqa
137d6af0b95a26d575a6f170d2cd4f7b456570f6620b51e2aee6fc526e68f170
What is the date mentioned ? Make the answer very short.
February 6 , 1996.
docvqa
137d6af0b95a26d575a6f170d2cd4f7b456570f6620b51e2aee6fc526e68f170
To whom this letter is written ? Provide a succinct answer.
Dr. K. KItazawa.
docvqa
137d6af0b95a26d575a6f170d2cd4f7b456570f6620b51e2aee6fc526e68f170
This letter is written by whom ? Make the answer very short.
T. Suzuki.
docvqa
137d6af0b95a26d575a6f170d2cd4f7b456570f6620b51e2aee6fc526e68f170
Which laboratory is T. Suzuki associated with ? Offer a very short reply.
Drug safety research laboratories .
docvqa
7841c857cc2aa66a8c2908971befd2d4112e373ff15c6562c96a17cead7f0191
What is the date mentioned in the letter Give a very brief answer.
August 8 , 2002.
docvqa
7841c857cc2aa66a8c2908971befd2d4112e373ff15c6562c96a17cead7f0191
What is the name of the industry given here? Make the answer very short.
Takeda chemical industries, LTD .
docvqa
7841c857cc2aa66a8c2908971befd2d4112e373ff15c6562c96a17cead7f0191
To whom this letter is written ? Keep it short and to the point.
Dr. Thom.
docvqa
7841c857cc2aa66a8c2908971befd2d4112e373ff15c6562c96a17cead7f0191
What is the name mentioned in cc Offer a terse response.
Mr . S . Hamanaka.
docvqa
7841c857cc2aa66a8c2908971befd2d4112e373ff15c6562c96a17cead7f0191
Who sent this letter? Your response must be concise.
Katsuhisa Saito.
docvqa
7841c857cc2aa66a8c2908971befd2d4112e373ff15c6562c96a17cead7f0191
What is ref: code mentioned ? Give a very brief answer.
TPNA-TS-020808.
docvqa
e7c85417d65fb2b88d67b9cab110134b28667834acc6fe2a8263ddd0d7aa5756
What is the venue mentioned in the document? Your answer should be very brief.
TPNA, Chicago.
docvqa
e7c85417d65fb2b88d67b9cab110134b28667834acc6fe2a8263ddd0d7aa5756
What is the date mentioned in the document? Offer a terse response.
Monday, 12 and Tuesday, 13 August 2002.
docvqa
e7c85417d65fb2b88d67b9cab110134b28667834acc6fe2a8263ddd0d7aa5756
What is the fax number mentioned in the letter at the top? Provide a succinct answer.
06 6204 2244.
docvqa
e7c85417d65fb2b88d67b9cab110134b28667834acc6fe2a8263ddd0d7aa5756
Which drug's toxicity study results will be discussed ? Make the answer very short.
Pioglitazone.
docvqa
e7499dbbbca5135763b34f462e7aef7b15f0c9d009a19a79988c77531e9b6330
What is the date and time mentioned ? Provide a succinct answer.
10/27/93 09:36:07.
docvqa
e7499dbbbca5135763b34f462e7aef7b15f0c9d009a19a79988c77531e9b6330
What is mentioned in the subject ? Offer a terse response.
Pioglitazone statement.
docvqa
e7499dbbbca5135763b34f462e7aef7b15f0c9d009a19a79988c77531e9b6330
To whom this email was send? Offer a terse response.
PETER J. DANIELS.
docvqa
e7499dbbbca5135763b34f462e7aef7b15f0c9d009a19a79988c77531e9b6330
What is the date mentioned in the forwarding note ? Offer a terse response.
10/26/93 15:44.
docvqa
e7499dbbbca5135763b34f462e7aef7b15f0c9d009a19a79988c77531e9b6330
What is the time mentioned in the forwarding note ? Give a very brief answer.
15:44.
docvqa
e7499dbbbca5135763b34f462e7aef7b15f0c9d009a19a79988c77531e9b6330
To whom this email was forwaded? Give a very brief answer.
PLRUPPEL--RCC1 RUPPEL, PATRICIA.
docvqa
cc353e21b51a7b66a083a05f0899245ff1db02e7acc7a2ec10f21b81163ee296
What is the name of the company Offer a terse response.
THE UPJOHN COMPANY.
docvqa
cc353e21b51a7b66a083a05f0899245ff1db02e7acc7a2ec10f21b81163ee296
What is the date and year mentioned ? Your answer should be very brief.
September 21, 1993.
docvqa
cc353e21b51a7b66a083a05f0899245ff1db02e7acc7a2ec10f21b81163ee296
Which company is mentioned in the letterhead? Provide a short and direct response.
THE UPJOHN COMPANY.
docvqa
cc353e21b51a7b66a083a05f0899245ff1db02e7acc7a2ec10f21b81163ee296
In which country the upjohn company is located ? Give a very brief answer.
U.S.A.
docvqa
fbd88b7577c4e860b7847d238709545b6b829426d3fdd438a7506d89f44d56eb
What is the fax mentioned ? Provide a succinct answer.
06 6204 2244.
docvqa
fbd88b7577c4e860b7847d238709545b6b829426d3fdd438a7506d89f44d56eb
What is year date and time mentioned? Make the answer very short.
2002 08/08 21:49.
docvqa
fbd88b7577c4e860b7847d238709545b6b829426d3fdd438a7506d89f44d56eb
What is the name of the division ? Make the answer very short.
Takeda Develop division.
docvqa
fbd88b7577c4e860b7847d238709545b6b829426d3fdd438a7506d89f44d56eb
To whom they can ask directly to disclose the details of "promotion study"? Make the answer very short.
FDA.
docvqa
986a7319cafc460ff805f2a4134db11156cdce345cf50b1bccc7b0008f3201be
What is the date mentioned in the letter Ensure brevity in your answer.
8 january 2003.
docvqa
986a7319cafc460ff805f2a4134db11156cdce345cf50b1bccc7b0008f3201be
To whom this letter is addressed? Give a very brief answer.
MPDRAP I Leader.
docvqa
986a7319cafc460ff805f2a4134db11156cdce345cf50b1bccc7b0008f3201be
What is mentioned in the cc? Your answer should be very brief.
CEOs and General Managers of Pharmaceutical Units.
docvqa
986a7319cafc460ff805f2a4134db11156cdce345cf50b1bccc7b0008f3201be
Combination therapy in the us market accounts for how much % of total actos sales . Make the answer very short.
64.
docvqa
e3889dedcc8c42890cc5c4c3a76f822607d682ae5634a99d1b2594b4c682fb02
What is the due date to evaluate data from actos 507? Give a very brief answer.
August 5.
docvqa
e3889dedcc8c42890cc5c4c3a76f822607d682ae5634a99d1b2594b4c682fb02
Who is the lead responsibility for developing additional monitoring plan for actos 508 Your response must be concise.
Amy hagaman.
docvqa
e3889dedcc8c42890cc5c4c3a76f822607d682ae5634a99d1b2594b4c682fb02
What is the due date for "draft justification for actos 508" ? Offer a very short reply.
August 12.
docvqa
e3889dedcc8c42890cc5c4c3a76f822607d682ae5634a99d1b2594b4c682fb02
When was this last updated ? Ensure brevity in your answer.
August 1, 2002.
docvqa
e3889dedcc8c42890cc5c4c3a76f822607d682ae5634a99d1b2594b4c682fb02
Who is the lead responsible person for draft justification for actos 508? Provide a succinct answer.
Amy Hagaman/Alfonso Perez.
docvqa
e3889dedcc8c42890cc5c4c3a76f822607d682ae5634a99d1b2594b4c682fb02
How many pages are there in total as part of this document? Offer a terse response.
7.
docvqa
dd17528fdf309aec4ac3609d484926a5bf820cf93af2709f913dcb2624d3886a
Which is the core organization of Takeda pharmaceutical Company? Your answer should be compact.
Pharmaceutical development Division.
docvqa
dd17528fdf309aec4ac3609d484926a5bf820cf93af2709f913dcb2624d3886a
Who made the opening remarks ? Your answer should be compact.
Dr. Kitazawa.
docvqa
dd17528fdf309aec4ac3609d484926a5bf820cf93af2709f913dcb2624d3886a
When is the clinical expert meeting scheduled? Your response must be concise.
October 1 and 2.
docvqa
dd17528fdf309aec4ac3609d484926a5bf820cf93af2709f913dcb2624d3886a
Why was it suggested to prepare non-clinical "White paper"? Make the answer very short.
To address the bladder issue.
docvqa
dd17528fdf309aec4ac3609d484926a5bf820cf93af2709f913dcb2624d3886a
What is Ms Wakamatsu's role in Dept. Strategic Development? Give a very brief answer.
Assistant manager.
docvqa
6ada9f853a6d2f11603c0807dc306143f874d17d9e592a3df8e83578669f04cf
What is the date mentioned in the given information ? Your answer should be very brief.
20 April 2006.
docvqa
6ada9f853a6d2f11603c0807dc306143f874d17d9e592a3df8e83578669f04cf
What is the meeting time mentioned here? Offer a terse response.
4:00pm - 5:00pm.
docvqa
6ada9f853a6d2f11603c0807dc306143f874d17d9e592a3df8e83578669f04cf
What is the place mentioned ? Make the answer very short.
Meeting room 403.
docvqa
6ada9f853a6d2f11603c0807dc306143f874d17d9e592a3df8e83578669f04cf
Who will forward the article regarding rosiglitazone and non clinical bladder data to andy ? Your answer should be very brief.
Mondira.
docvqa
6ada9f853a6d2f11603c0807dc306143f874d17d9e592a3df8e83578669f04cf
What date is the meeting scheduled to develop the overall structure of the document? Make the answer very short.
In early may.
docvqa
e37155b5e153878a1f9a0ac3310bfcf07d12187e59e5681cbc3e2a54dbbe6580
Who presented an outline of the Cohen hypothesis? Your answer should be compact.
Philip Collett.
docvqa
e37155b5e153878a1f9a0ac3310bfcf07d12187e59e5681cbc3e2a54dbbe6580
What is significant in the development of calculi? Your response must be concise.
Raising the pH of male rat urine above 6.5.
docvqa
e37155b5e153878a1f9a0ac3310bfcf07d12187e59e5681cbc3e2a54dbbe6580
What is the correlation observed in cohen's paper? Ensure brevity in your answer.
0.61.
docvqa
e37155b5e153878a1f9a0ac3310bfcf07d12187e59e5681cbc3e2a54dbbe6580
Why didn't rats eliminate calculi as humans do? Provide a short and direct response.
Because rats are quadropeds.
docvqa
e37155b5e153878a1f9a0ac3310bfcf07d12187e59e5681cbc3e2a54dbbe6580
Who challenged authorities regrading implementing monitoring plan? Your answer should be very brief.
Takeda Europe.
docvqa
e37155b5e153878a1f9a0ac3310bfcf07d12187e59e5681cbc3e2a54dbbe6580
What content is high in male rat urine? Give a very brief answer.
Protien content.
docvqa
1e169aa541822dc98eccc16d6dd778cdce30cc9af9e566bdff25b38411d59c48
What is the fullform of MAA? Ensure brevity in your answer.
Marketing Authorization Application.
docvqa
1e169aa541822dc98eccc16d6dd778cdce30cc9af9e566bdff25b38411d59c48
Which forum is mentioned in this document? Your answer should be very brief.
Takeda Global Risk Management Forum.
docvqa
827223ec75540232069e94651d6b8b637e3ddc47740380584dda10c0d83bbea2
What is the issued date of this document? Make the answer very short.
August 13, 2002.
docvqa
827223ec75540232069e94651d6b8b637e3ddc47740380584dda10c0d83bbea2
Who is the Director of Nonclinical Safety and Efficacy? Keep it short and to the point.
David Baron.
docvqa
827223ec75540232069e94651d6b8b637e3ddc47740380584dda10c0d83bbea2
Who described tumor promoter-model study? Provide a succinct answer.
Dr. El-Hage.
docvqa
827223ec75540232069e94651d6b8b637e3ddc47740380584dda10c0d83bbea2
What is the duration of daily dosing? Ensure brevity in your answer.
32-weeks after BBN.
docvqa
827223ec75540232069e94651d6b8b637e3ddc47740380584dda10c0d83bbea2
What is the exhibit number? Give a very brief answer.
107.
docvqa
e86ffa9a9f68a374ffd8be9e09c1e4a78e513b1ce005a7ee78e629e0e082ef25
Who updated the CEO on August 6? Provide a succinct answer.
Mr. Saito.
docvqa
e86ffa9a9f68a374ffd8be9e09c1e4a78e513b1ce005a7ee78e629e0e082ef25
By when should TPNA send outline of response to TCI ? Offer a very short reply.
By august 19.
docvqa
e86ffa9a9f68a374ffd8be9e09c1e4a78e513b1ce005a7ee78e629e0e082ef25
When will Mr. Saito present outline to CEO? Provide a short and direct response.
August 20.
docvqa
e86ffa9a9f68a374ffd8be9e09c1e4a78e513b1ce005a7ee78e629e0e082ef25
By when will the document be finalized? Offer a terse response.
August 26.
docvqa
8ddbfdff7e9c5ec673146915c432be493e913e6a36410eddc4950fa730e43f08
When will the FDA Conference Call be held? Provide a succinct answer.
July 31, 2002.
docvqa
8ddbfdff7e9c5ec673146915c432be493e913e6a36410eddc4950fa730e43f08
On the purpose of teleconference, how many topics were to be discussed? Provide a succinct answer.
3 topics.
docvqa
8ddbfdff7e9c5ec673146915c432be493e913e6a36410eddc4950fa730e43f08
What is the date mentioned at the bottom? Your response must be concise.
09/18/12.
docvqa
79463ad1324ef31cd1e4eba0f9f443d1db23035648a518a79dbff7aab00b7bf0
What is the heading of the document? Provide a short and direct response.
ACTOS FDA RESPONSE TASK FORCE-TPNA.
docvqa
79463ad1324ef31cd1e4eba0f9f443d1db23035648a518a79dbff7aab00b7bf0
How many key issues does the FDA have with respect to the non-clinical data related to bladder tumors? Your answer should be compact.
The FDA has 3 key issues with respect to the non-clinical data related to bladder tumors.
docvqa
79463ad1324ef31cd1e4eba0f9f443d1db23035648a518a79dbff7aab00b7bf0
What plan is developed by TPNA? Provide a short and direct response.
TPNA will develop monitoring plan.
docvqa
79463ad1324ef31cd1e4eba0f9f443d1db23035648a518a79dbff7aab00b7bf0
What is TPNA's goal? Ensure brevity in your answer.
Is to supply justification to support maintaining current labeling.
docvqa
7538f184d27f9026d6d315ee08bc9528d3553fdee0e0f2e1f05d8b91caa9774c
When was this document last updated? Make the answer very short.
August 1, 2002.
docvqa
7538f184d27f9026d6d315ee08bc9528d3553fdee0e0f2e1f05d8b91caa9774c
What is the last point in the table? Provide a short and direct response.
Evaluate Impact on Tak-559.
docvqa
7538f184d27f9026d6d315ee08bc9528d3553fdee0e0f2e1f05d8b91caa9774c
What is the Draft's Due Date? Offer a very short reply.
August 5.
docvqa
650b6c6fa1dd620d0964dd539fdec18fd8ec253993d428b0f4436de9c5d4a998
What kind of meeting is mentioned in this letter? Offer a terse response.
ACTOS FDA RESPONSE MEETING.
docvqa
650b6c6fa1dd620d0964dd539fdec18fd8ec253993d428b0f4436de9c5d4a998
What kind of drug is used to treat the group of rats? Ensure brevity in your answer.
Pioglitazone.
docvqa
650b6c6fa1dd620d0964dd539fdec18fd8ec253993d428b0f4436de9c5d4a998
What kind of cell tumours experienced the same frequency when group of rats treated with pioglitazone? Your response must be concise.
Transitional cell tumors.
docvqa
919c81ea5c4f02f134c4d968639f748c7d710d1a33c614c78475c737eccfa876
In the rat oncogenicity study, what was observed in male rats? Give a very brief answer.
Thickening of the bladder and hypertrophy of the urothelium.
docvqa
919c81ea5c4f02f134c4d968639f748c7d710d1a33c614c78475c737eccfa876
What is the time span where no tumors are seen? Your answer should be very brief.
Shorter term (12 month).
docvqa
919c81ea5c4f02f134c4d968639f748c7d710d1a33c614c78475c737eccfa876
According to mouse oncogenicity study, what was seen male mice only? Your answer should be compact.
Hyperplasia.
docvqa
919c81ea5c4f02f134c4d968639f748c7d710d1a33c614c78475c737eccfa876
Who conducted robust program? Your answer should be very brief.
TCI.
docvqa
d193e0ca5bfbaca218b39d9874bd8bf8adafb81a333ecc47828b3820cf415866
What is the due date to conduct review meeting for FDA package? Offer a very short reply.
August 22.
docvqa
d193e0ca5bfbaca218b39d9874bd8bf8adafb81a333ecc47828b3820cf415866
Who is the lead responsible person for the compilation of FDA package? Your answer should be compact.
Larry Hancock.
docvqa
d193e0ca5bfbaca218b39d9874bd8bf8adafb81a333ecc47828b3820cf415866
What is the task assigned to David Baron? Your answer should be compact.
Send nonclinical rationale/justification section to medical writing for compilation.
docvqa
d193e0ca5bfbaca218b39d9874bd8bf8adafb81a333ecc47828b3820cf415866
Who is responsible for sending package to TCI/EU for review? Offer a terse response.
Mary Ramstack.
docvqa
d193e0ca5bfbaca218b39d9874bd8bf8adafb81a333ecc47828b3820cf415866
What is the due date for sending FDA Document to Regulatory Affairs? Keep it short and to the point.
August 26.
docvqa
d193e0ca5bfbaca218b39d9874bd8bf8adafb81a333ecc47828b3820cf415866
What is the last updated date mentioned in this document? Make the answer very short.
August 1, 2002.
docvqa
49899848bd18ca4b495deae7452c1ef406b0566d4692666a6ca6bd4b2650a6f7
Which product's liability claims are described here? Make the answer very short.
ACTOS PRODUCTS.
docvqa
49899848bd18ca4b495deae7452c1ef406b0566d4692666a6ca6bd4b2650a6f7
What is the date mentioned in this document at the bottom? Offer a very short reply.
1/11/2007.
docvqa
49899848bd18ca4b495deae7452c1ef406b0566d4692666a6ca6bd4b2650a6f7
What is the exhibit number? Offer a very short reply.
52.
docvqa