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Standards & Regulation

Business & Regulation Standards & Regulation

The Underworld of Counterfeit Fentanyl

| Jamie Irvine | 6 min read

A deep dive into the dangers of fentanyl entering the US supply chain – and the importance of the Drug Supply Chain Security Act

Manufacture Advanced Medicine

The World’s First CRISPR-Based Therapeutic Approval

| Stephanie Vine | 3 min read

It’s official: CRISPR medicines are here as UK authorizes exa-cel.

Business & Regulation Standards & Regulation

Nowhere to Hide

| Rob Coker | 2 min read

Never underestimate the meticulousness with which authorities operate or the standards that businesses are expected to adhere to.

Business & Regulation Standards & Regulation

FDA Warning Letters: September 2023 Edition

| Stephanie Vine | 4 min read

A look at cGMP deviations in recent warning letters, including manufacturing conducted in corridors and equipment uncleaned for 14 years.

Manufacture Process Control

Rent to Reduce

| Stephen Harding | 3 min read

Is renting material handling equipment the best way to help manufacturers tackle waste?

Manufacture Small Molecules

Making Your Mark

| Jim Gastle, Grant Peters | 4 min read

US-based law and patenting experts offer their thoughts on IP protection in the digital age

Manufacture Small Molecules

The Contaminated Childrens’ Cough Syrup Scandal

| Stephanie Vine | 4 min read

I explore recent cases of pediatric cough medicines contaminated with diethylene glycol.

Business & Regulation Standards & Regulation

Why Are Some Medicines Linked to Suicide?

| Stephanie Vine | 3 min read

The EMA is reviewing whether certain Novo Nordisk drugs are linked to suicidal thoughts

Discovery & Development Drug Discovery

A Call to Arms for Antimicrobial Resistance

| Peter Jackson | 13 min read

Investment into new antimicrobial therapies has been lacking for decades – and now we’re now paying the price.

Business & Regulation Business Practice

Never Break the Chain

| Nadine Lampka | 5 min read

How do we prevent criminals from reusing primary packaging for counterfeit medicines? Labeling solutions and other creative concepts can help.

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