BioPharma Drive: Drug Pricing

AUGUST 29, 2024

Testimony from the heads of Express Scripts, Optum Rx and Caremark in July defending pharmacy benefit managers’ business practices could be coming back to bite them.

Testimonials 254

Testimonials Pharmacy 254

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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FDA Science Regulations Production 40

Agency IQ

JUNE 16, 2023

to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug. The rule, will also, if finalized, address communication with State boards of pharmacy. The final rule will amend the administrative destruction provisions in 21 CFR 1.94

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Regulations FDA Science Production 40

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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FDA Science Regulations Production 40

FDA Law Blog: Biosimilars

APRIL 8, 2024

pharmacy benefit managers (PBMs), group purchasing organizations (GPOs), wholesale distributors) play before a finished product ever makes it to a patient. Section I.C of the White Paper states, accurately, that “factors that cause drug shortages are multi-faceted and involve many market participants.”

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Drugs FDA Hospitals Government 59

Agency IQ

JUNE 17, 2024

As reported by POLITICO , “The decision — if allowed by the Supreme Court to take effect — would roll back actions the federal government has taken since 2016 to make the pills more accessible, including rules allowing online ordering, mail delivery, and pharmacy dispensing of the drugs.

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FDA Doctors Testimonials Regulations 40

FDA Law Blog: Biosimilars

FEBRUARY 18, 2025

Hull A recent DEA decision revoking the registration of a Louisiana pharmacy sheds light on the Agencys approach to crediting one experts testimony over that of another expert during an administrative hearing. In Neumanns Pharmacy, LLC , 90 Fed. Whats the take away?

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Testimonials Pharmacy Government Drugs 69