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Standards & Regulation

Business & Regulation Small Molecules

Let’s Modernize Manufacturing

| Stephanie Sutton

The FDA’s Janet Woodcock explains how manufacturing will change in the coming years.

Business & Regulation Analytical Science

Banking for Bioassays

| Mike Merges and Mike Sadick

Analytical bioassay cell banks certainly have benefits. But it can be difficult to know what best practices to follow.

Manufacture Clinical Trials

A Tall Task

| Roisin McGuigan

The PRGLAC Task Force hopes to change the landscape for research on pregnant and lactating women.

Business & Regulation Clinical Trials

Including Pregnant Women from the Start

| Catherine Spong

Including pregnant women in research isn’t as difficult as some might think…

Business & Regulation Clinical Trials

A Pharma Success Story

| Eric Gervais

One pharma company is working to pioneer safer drugs for use during pregnancy…

Manufacture Clinical Trials

Pregnant Patients Deserve Better

| Anne Drapkin Lyerly

The lack of evidence available from pharma companies to guide care of pregnant women is ethically unacceptable.

Manufacture Clinical Trials

Time for Pharma to Deliver?

| Roisin McGuigan

Is pharma putting women and children last?

Business & Regulation Standards & Regulation

The True Cost of Falsified Medicine

| Roisin McGuigan

A recent review and meta-analysis highlights the huge impact of fake and substandard drugs.

Manufacture Clinical Trials

Right for Patients?

| Ellen Sigal

“Right to Try” legislation may have compassion at its heart, but it does not do enough to ensure patient protection.

Manufacture Standards & Regulation

The Costs of the Counterfeit Battle

| Maarten Van Baelen

Fighting counterfeit medicines is a noble goal, but the financial burden of safety features may affect access to medicines in unintended ways.

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