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Gregory Glass

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Gregory Glass
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gregoryglass

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@gregoryglass

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Product: Roxadustat
Company: Fibrogen and AstraZeneca
Petition Filer: Epstein Becker, a law firm
Petition Number(s): 2020P-2193
Date of Petition: November 16, 2020
Responding Petitions:

Issue and Implication: Whether current FDA standards for approving drugs is sufficient to ensure that the drug’s benefits outweigh its r…[Read more]

Profile picture of gregoryglass 2 weeks ago

Product: Vancomycin Oral Solution
Company: ANI
Petition Filer: Lachman Consultants
Petition Number(s): 2020P-2187
Date of First Petition: November 16, 2020
Responding Petitions:

Action Requested of Petition: The Petitioner would like to submit an ANDA and manufacture vancomycin oral solution EQ 125 mg (base)/5 mL. It is basing the…[Read more]

Profile picture of gregoryglass 2 weeks ago

Product: Micro-K® LS Packets (potassium chloride) ER Liquid Suspension
Company: KV Pharmaceutical
Petition Filer: Hymen Phelps, a law firm
Petition Number(s): 2020P-2181
Date of First Petition: November 12, 2020
Responding Petitions: None

Action Requested of Petition: Petitioner would like FDA to approve a submission for a 8 mEq…[Read more]

Profile picture of gregoryglass 2 weeks, 4 days ago
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