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Research Criteria and Technical Notes

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Product: Technetium Tc-99m Injection
Company: GE Healthcare
Petition Filer: Hymen Phelps, a law firm
Petition Number(s): 2021P-0959
Date of Petition: September 1, 2021
Responding Petitions:

Action Requested by Petitioner: The petitioner would like to FDA to determine whetherTechnetium Tc-99m Injection also referred to as MPS DMSA…Read more

Profile picture of gregoryglass 3 weeks, 4 days ago

Product: Glucotrol®(glipizide) Tablets
Company: Pfizer
Petition Filer: Hymen Phelps, a law firm
Petition Number(s): 2021P-0939
Date of Petition: August 26, 2021
Responding Petitions:

Action Requested by Petitioner: The petitioner would like to FDA to determine whether the 2.5mg tablet form of Glucotrol®(glipizide) Tablets (NDA 0…Read more

Profile picture of gregoryglass 1 month ago

Product: Simufilam
Company: Cassava Sciences
Petition Filer: Labaton Sucharow, a law firm
Petition Number(s): 2021P-0930
Date of Petition: August 23, 2021
Responding Petitions:

Issue and Implication: Whether two research papers are sufficient to justify an Investigational New Drug study.

Action Requested by Petitioner: The…Read more

Profile picture of gregoryglass 1 month ago
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