Drug Channels

JULY 11, 2022

Informa Connect's Hub and Specialty Pharmacy Models West. September 14-15, 2022 Sheraton San Diego Hotel & Marina | San Diego, CA www.informaconnect.com/hub-specialty-pharmacy-west. Offer not valid on workshop only or academic/non-profit registrations. Delivered as a Hybrid Event. Attorney’s Office District of NJ Gustav W.

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Specialty Pharmacies Pharmacy Biosimilars Compliance 98

Drug Channels

OCTOBER 23, 2023

A program driven by market dynamics and led by champions of channel strategy, join now to master the complexities of pharmacy and distribution models to accelerate market access –It's all happening December 11-13, 2023. What can you expect?

Pharmacy 75

Pharmacy Biosimilars Production Marketing 75

Drug Channels

NOVEMBER 8, 2021

Join your industry counterparts this December to unravel the complexities of the channel, navigate high-impact topics transforming trade and benchmark winning pharmacy and distribution frameworks. Offer not valid on workshop only or academic/non-profit registrations. Meet The Expert Faculty. Drug Channels, or any of its employees.

Specialty Pharmacies 75

Specialty Pharmacies Pharmacy Biosimilars Marketing 75

Agency IQ

OCTOBER 20, 2023

BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions This week, FDA and its grantees briefed stakeholders on the status of research projects funded through the Biosimilar User Fee Act (BSUFA III) Regulatory Science Pilot Program. Developing biosimilars is an extensive and expensive process.

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Science Biosimilars FDA Production 40

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

DECEMBER 1, 2023

Title Type Date Cleared by OIRA Legal Deadline None Notable FDA Comment Periods Closing in December and January FDA comment periods are typically open for 30-60 days, unless they are extended.

FDA 40

FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

Title Type Comments Close Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief Guidance November 1 Post-Warning Letter Meetings Under GDUFA Guidance November 6 In-Home (..)

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FDA Science Regulations Production 40