↓
 

Gregory Glass

FDA Petitions

Gregory Glass
  • FDA Petitions Home
  • Editor’s Note
  • The Petition Process
  • FDA Petitions Database
    • Get Access
Home→gregoryglass

gregoryglass

Profile picture of gregoryglass

@gregoryglass

active 1 day, 3 hours ago
  • Home
  • Activity
  • Profile
  • Forums
  • View

View Profile

Latest updates

Product: Dicloxacillin Sodium Capsules
Company: Teva and Sandoz
Petition Filer: Aurobindo
Petition Number(s): 2020P-1427
Date of Petition: May 28, 2020
Responding Petitions:

Issue and Implication: Whether FDA can designate a second Reference Standard when the current RS is in limited supply.

Action Requested by Petitioner: The…[Read more]

Profile picture of gregoryglass 6 days, 4 hours ago

Product: Impoyz®(clobetasol) Topical Cream
Company: Encore Dermatology
Petition Filer: Encore Dermatology
Petition Number(s): 2020P-1421
Date of Petition: May 27, 2020
Responding Petitions:

Issue and Implication: Whether an ANDA product must have identical ingredients to achieve bioequivalency and safety and efficacy.

Action…[Read more]

Profile picture of gregoryglass 1 week ago

Product: Vibramycin®(doxycycline) Injection
Company: Pfizer/Fresenius Kabi
Petition Filer: Hymen Phelps
Petition Number(s): 2020P-1403
Date of Petition: May 20, 2020
Responding Petitions:

Issue and Implication: Whether an ANDA can serve as a Reference List Drug when it contains a non-exception excipient.

Action Requested by…[Read more]

Profile picture of gregoryglass 2 weeks ago
FDAPetitions.com™ is a trademark of Parry Ashford Inc. • ©Parry Ashford Inc. 2020
↑