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Newsletter, April 17, 2025

FDA Signals Reduced Emphasis on Animal Testing For Drug Approvals

Sex-Specific Data in Medical Device Trials: FDA’s Latest Guidance Document

​Newsletter, April 10, 2025

EMA Advice on How to Use Real World Data

LDTs are Back: This Time it May be for Good

​Newsletter, March 27, 2025

Why Randomized Trials Matter: The Case for Controlled Trials

FDA Flags Serious Data Falsification at a Chinese Medical Device Testing Facility

​Newsletter, March 20, 2025

Developing Treatments for Rare Disease: FDA’s Case Studies

Beyond Government Grants: A Diversified Funding Strategy for Drug Development

​Newsletter, March 13, 2025

Chasing Profits: The Drug Companies' Ethical Dilemma

Can AI Replace Doctors in Patient Care Conversations?

Newsletter, February 27, 2025

Surprise, Social Media Promotion of Medical Testing is Deceptive

Improper Donor Testing at IVF Clinic: FDA Warning Letter

Newsletter, February 20, 2025

Will FDA’s Political Vulnerability Influence What New Drugs Are Approved?

Should You Delay Your Submissions if Your FDA Review Team Got Fired?

Newsletter, February 20, 2025

Will FDA’s Political Vulnerability Influence What New Drugs Are Approved?

Should You Delay Your Submissions if Your FDA Review Team Got Fired?

Newsletter, February 13, 2025

How Hard is it to Conduct Clinical Trials in the US?

Conducting Trials with Supplements Without an IND Gets a Warning Letter

Newsletter, February 6, 2025

What Does DeepSeek Teach the Pharma Developers?

Does Your IRB Have These 55 SOPs? FDA Gives a List

Newsletter, January 30, 2025

Does Diversity in Clinical Trials Still Matter to the FDA?

Why is There No Treatment for Long Covid Years After the Pandemic?

Newsletter, January 23, 2025

Why Investigating Deviation is Critical for GMP Compliance

How to Collect Biopsies in Clinical Trials

Newsletter, January 16, 2025

Accelerated Approval Pathway’s New Stricter Requirement

Newsletter, January 9, 2025

FDA Releases a Record 31 New Guidance Documents in 2 Days: Is It an Anomaly?

New Drug Approvals in 2024: What is the Fine Print?

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