Agency IQ

AUGUST 4, 2023

a wholesaler or pharmacy) would be able to see a valid chain of custody for a product. For example, as of January 1, 2015, manufacturers needed to have in place systems to comply with requirements related to the management of suspect and illegitimate products, verification requests, and the maintenance of an electronic database.

FDA 40

FDA Science Production Packaging 40

Agency IQ

JANUARY 26, 2024

In some cases, manufacturers have determined that specific drug products have limited stability when the original packaging is opened. For example, the stability of the oral anticoagulant Pradaxa (dabigatran; Boehringer Ingelheim) is compromised once the original packaging is opened due to concerns related to moisture.

Science 40

Science FDA Production Packaging 40

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. ]

Regulations 40

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.

FDA 40

FDA Science Regulations Production 40

Drug Target Review

SEPTEMBER 6, 2024

VIVEbiotech is involved in the manufacture of more than 50 different LVVs since 2015, eight of these programmes being for in vivo applications. Mainly, I would highlight the use of different pseudotypes, optimised packaging plasmids and modified cell lines to increase targeting of lentiviral vectors.

Therapies 59

Therapies Vaccine Marketing Disease 59

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

OCTOBER 14, 2020

“Since 2015, BARDA has partnered with Regeneron to develop a life-saving treatment for Ebola Zaire. Regeneron is actively working with non-governmental organizations and public health agencies to ensure continued access to Inmazeb in low- and middle-income countries.

FDA Approval 52

FDA Approval FDA Production Treatment 52