European Pharmaceutical Review

NOVEMBER 15, 2022

This aligns well with newly-issued FDA draft guidance on Computer Software Assurance, which states: “Because the computer software assurance effort is risk-based, it follows a least-burdensome approach, where the burden of validation is no more than necessary to address the risk.” FDA, 2022. . About the authors.

Manufacturing 84

Manufacturing Pharma Food and Drug Administration Safety 84

European Pharmaceutical Review

SEPTEMBER 25, 2023

References Component Testing Gains Prominence in Drug Product GMP Warning Letters as FDA Focus Intensifies on OTC Topicals and Upstream Supply Chain [Internet]. 2002; 74(8): 1760–71. IPQ International Pharmaceutical Quality. Cited 2023Feb]. Available from: [link] Egelhofer V, Gobom J, Seitz H, et al. Meert C, Guo A, Novick S, et al.

Pharmaceutical 95

Pharmaceutical Manufacturing Food Electronics 95

European Pharmaceutical Review

FEBRUARY 14, 2023

In August 2021, mRNA-1345 gained Fast Track designation from the US Food and Drug Administration (FDA) in adults over 60 years old. OTX-2002, the first mRNA therapy to target c-Myc (MYC) oncogene overexpression, could be the first programmable epigenetic medicine.” billion during 2028, GlobalData forecasted in its report.

Food and Drug Administration 90

Food and Drug Administration Medicine Safety Consulting 90

pharmaphorum

SEPTEMBER 13, 2022

2001– FDA green lights revolutionary treatments. Just over a decade after it was developed by biochemist Nicholas Lyndon, Imatinib received US Food and Drug Administration (FDA) approval in 2001. 2002 – Emergence of CAR-T therapy. However, the first generation of CAR T-cells proved to be clinically ineffective.

Food and Drug Administration 90

Food and Drug Administration Patients Engineering Physicians 90

World of DTC Marketing

MARCH 17, 2022

The mortality rate from lung cancer has dropped in recent decades—by 56% in men from 1990 to 2019 and by 32% in women from 2002 to 2019. This leads to an ethical question: Should we deny hope to cancer patients because a drug may not work, or should the FDA only approve cancer drugs that show significant clinical benefits (i.e.,

Food and Drug Administration 255

Food and Drug Administration Medical Ethics Patients 255

PM360

JULY 13, 2023

The FDA has granted Fast Track Designation for our HER2-targeted ADC, ARX788, and we are enrolling the signal-seeking ACE-Breast-03 Phase 2 clinical study in post-Enhertu mBC patients throughout 2H 2023. Our lead indications are HER2-positive metastatic breast cancer (mBC) and metastatic castration-resistant prostate cancer (mCRPC).

Patients 98

Patients Engineering Side effects Leads 98

European Pharmaceutical Review

SEPTEMBER 22, 2023

Limitations of monoclonal antibody therapies Regulatory approvals from the US Food and Drug Administration (FDA) for aducanumab and lecanemab – and likely very soon for donanemab also – opened a route for different therapeutic modalities and other relevant disease targets, such as tau.

Food and Drug Administration 77

Food and Drug Administration Safety Patients Leads 77