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Standards & Regulation

Manufacture Biosimilars

It’s Complicated

| Bérangère Tissot

The potential market for complex generics is substantial, but navigating the FDA’s guidance for proving “sameness” is a real minefield...

Business & Regulation Standards & Regulation

The 411 on the US Government Shutdown

| Maryam Mahdi

What did the partial government shutdown mean for the US pharma industry?

Business & Regulation Standards & Regulation

A Knight's Tale

| Maryam Mahdi

Sitting Down With… Sir Alasdair Breckenridge; Chairman of the Advisory Board, the Centre of Regulatory Excellence of the Government of Singapore...

Business & Regulation Standards & Regulation

Proactive Policies

| Maryam Mahdi

Gearing up for 2019, the EMA shares revised guidelines to better protect the environment.

Business & Regulation Standards & 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 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…

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