Agency IQ

SEPTEMBER 15, 2023

The FDA took no apparent action following this meeting, and another Citizen Petition was filed in 2015 Petitioners Hendeles and Hatton came back in 2015 with a new Citizen Petition , again asking for the removal of phenylephrine products from the Final Monograph for OTC nasal decongestant drug products.

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Agency IQ

JUNE 16, 2023

To implement that authority, FDA published a final rule in the Federal Register on September 15, 2015 [80 FR 55237] which revised 21 CFR 1.94 The rule, will also, if finalized, address communication with State boards of pharmacy. Read our analysis of that rule here and here. ]

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Agency IQ

DECEMBER 11, 2023

As a result, products receiving approval due to their demonstrated safety and efficacy in the clinical trial setting may lack real-world effectiveness, with patients failing to see material benefit as they deal with persistent and severe side effects.

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Agency IQ

OCTOBER 27, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. The rule, will also, if finalized, address communication with State boards of pharmacy.

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Agency IQ

SEPTEMBER 29, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. The rule, will also, if finalized, address communication with State boards of pharmacy.

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Agency IQ

DECEMBER 1, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. The rule, will also, if finalized, address communication with State boards of pharmacy.

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