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Standards & Regulation

Discovery & Development Vaccines

Comirnaty for the Community?

| Stephanie Sutton

Pfizer-BioNTech COVID-19 vaccine receives full FDA approval.

Business & Regulation Business Practice

Seriously Y'all Stop It

| Stephanie Sutton

Pharma wants to empower patients to make informed healthcare decisions, but patients also need to be protected from misinformation.

Business & Regulation Standards & Regulation

Of Medicine and Machine Learning

| Angus Stewart, Stephanie Sutton

AI is expanding into medicine. Are the world’s regulators ready?

Business & Regulation Biosimilars

What Lies Ahead for Biosimilars?

| Stephanie Sutton

Sandoz’s Pierre Bourdage talks to us about biosimilars and how uptake can be boosted.

Business & Regulation Standards & Regulation

High Fines for High Prices

| Stephanie Sutton

Advanz Pharma is fined for substantially hiking the price of a generic drug.

Business & Regulation Standards & Regulation

The Winding Road to the Frontline for Advanced Therapies

| Angi Robinson

How can we ease the process of taking ATMPs to clinical trials? Two experts lay out the key considerations.

Business & Regulation Standards & Regulation

A Year Like No Other

| Maryam Mahdi

The EMA releases its annual report highlighting its achievements throughout 2020.

Business & Regulation Standards & Regulation

Watching the Future

| James Strachan

We sit down to interview Peter Marks, Director of the Center for Biologics Evaluation and Research at the US FDA.

Manufacture Standards & Regulation

Keeping Pace with the Plague

| Angus Stewart

Global regulators attended a virtual workshop on second generation COVID-19 vaccines – here’s what they talked about.

Manufacture Bioprocessing - Upstream & Downstream

Continuous Progress

| Doug Hausner

What role can regulators play in overcoming the barriers to the adoption of continuous manufacturing processes?


Latest White Papers

Overcoming the challenges of nitrosamine impurities in drugs

| Contributed by Thermo Fisher Scientific

HRAM LC-MS method for the determination of nitrosamine impurities in drugs

| Contributed by Thermo Fisher Scientific

LC-MS/MS method for the quantification of 10 nitrosamine impurities in metformin

| Contributed by Thermo Fisher Scientific

Early stage product development using laser diffraction analysis

| Contributed by Malvern Panalytical

All White Papers

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