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Standards & Regulation

Business & Regulation

Business-in-Brief

| Maryam Mahdi

Oscars of science, drug shortage reporting requirements, and a new gene therapy... What’s new for pharma in business?

Business & Regulation

Let’s Modernize Manufacturing

| Stephanie Sutton

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

Business & Regulation

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

A Tall Task

| Roisin McGuigan

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

Business & Regulation

Including Pregnant Women from the Start

| Catherine Spong

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

Business & Regulation

A Pharma Success Story

| Eric Gervais

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

Manufacture

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

Time for Pharma to Deliver?

| Roisin McGuigan

Is pharma putting women and children last?

Business & 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

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.


Latest White Papers

Early stage product development using laser diffraction analysis

| Contributed by Malvern Panalytical

Characterization of the size and concentration of liposomes

| Contributed by Malvern Panalytical

All White Papers

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December Issue of The Medicine Maker