pharmaphorum

JUNE 4, 2021

This article appears in our free digital magazine Deep Dive: Market Access 2021. Compounding this problem is the fact that the healthcare sector is often glacial in its pace of change, while digital innovations are evolving rapidly every year. The post “A long way to go” for digital health reimbursement appeared first on.

Compounding 45

Compounding FDA 45

ISPE

OCTOBER 26, 2022

For example, an assessment for a facility primarily focused on US and EU markets would only consider GMPs and regulations from EudraLex and the FDA. FDA CFR Title 21 Parts 211, 600, and 1271; 8. , FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing–Current Good Manufacturing Practice, 11.

Vaccines 97

Vaccines Compounding Documentation FDA 97

pharmaphorum

FEBRUARY 18, 2021

Eli Lilly’s Humalog compound and formulation patents expired in 2013 and 2014, respectively. In late 2017, the FDA approved Admelog, Sanofi’s biosimilar of Humalog. They employed hundreds of new salespeople to detail doctors and hospitals, spent millions on TV and magazine ads and handed out masses of free samples.

Prescription Filling 52

Prescription Filling Compounding FDA Communication 52

ISPE

OCTOBER 27, 2022

Since 2016, drug approvals per clinical campaign have outpaced the average across all modalities, resulting in 11 FDA-approved therapies in that span. A few innovators have shepherded this industry through these down years and managed to build impressive pipelines. Cell & Gene Therapy. Unlock Access to Member-Only Content. Company Name.

Process Improvement 98

Process Improvement Packaging Compounding Dosage 98

ISPE

MARCH 29, 2023

As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. Direct feedback from the US FDA on this pilot is shared in the discussion.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. Direct feedback from the US FDA on this pilot is shared in the discussion.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

AUGUST 30, 2022

With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. Recent US FDA data show that the lack of raw material availability contributes to 27% of drug shortages (see Appendix ). It is considered a moderate change by the FDA (CBE30) and NMPA.

Documentation 52

Documentation FDA Packaging Communication 52