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Standards & Regulation

Business & Regulation Standards & Regulation

So Long and Thanks for all the Drugs

| Stephanie Sutton

Scott Gottlieb prepares to leave the FDA after accomplishing much.

Business & Regulation Standards & Regulation

Tax Credits: Your Work is Worth it

| Peter Beavis

Research and development tax reliefs are available for businesses in many countries, but some companies are not taking advantage.

Business & Regulation Standards & Regulation

A Fairer Playing Field

| Maryam Mahdi

A recently published report shows how the European Commission has protected patients against anticompetitive practices over the last decade.

Business & Regulation Quality & Compliance

Batch Relief

| James Strachan

EU will allow companies to carry out QC testing in the UK after a "no deal" Brexit, at least under certain conditions and for a limited time.

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.

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