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.

Science 40

Science Biosimilars FDA Production 40

FDA Law Blog: Biosimilars

DECEMBER 4, 2023

Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. This post examines the Zarzamora pharmacy and prescribing red flags decision. d/b/a CVS/Pharmacy, Nos.

Pharmacy 139

Pharmacy Government Treatment Compliance 139

Drug Channels

DECEMBER 1, 2020

Pharmacy and healthcare provider markets experienced unprecedented volatility. During 2020, the COVID-19 pandemic disrupted every aspect of the pharmaceutical channel—and our lives. If all goes well, 2021 will begin our return to normalcy, as vaccines roll out across the country. This year has demonstrated the underlying resilience of U.S.

Pharmacy 52

Pharmacy Vaccine Drugs Pharmaceuticals 52

Agency IQ

FEBRUARY 15, 2024

We have tried to sort guidance documents by topic area.

FDA 40

FDA Science Biosimilars 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.

FDA 40

FDA Science Regulations 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.

FDA 40

FDA Science Regulations Production 40

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.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

AUGUST 21, 2020

In non-COVID-19 news, Amazon has entered the pharmaceutical market by launching ‘Amazon Pharmacy’ in India, while Johnson & Johnson is set to buy the Cambridge-based Momenta Pharmaceuticals for $6.5 Amazon Pharmacy launches in India. Amazon has entered the pharmaceutical market by launching ‘Amazon Pharmacy’ in India.

Biosimilars 52

Biosimilars Pharmacy Vaccine Pharmaceuticals 52

FDA Law Blog: Biosimilars

JUNE 23, 2024

However, the well-intentioned statutory language enacted in 1970 did not anticipate important changes in clinical therapies and advances in medical technology, and in some cases has created obstacles both to ensuring needed patient access and successful medical outcomes. 2] Why is this an issue? Highly concentrated opioid formulations (e.g.,

Nurses 98

Nurses Pharmacy Regulations Therapies 98