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Standards & Regulation

Business & Regulation Business Practice

Counterfeit Medicines: Getting On The Right Track

| 5 min read

Counterfeit deterrents are not yet available in some regions. We speak with Advanco CEO Alf Goebel to find out why.

Discovery & Development Ingredients

USP: A Mission Focused on Quality and Safety

| Chaitanya Koduri | 11 min read

Following on from deaths attributed to contaminated medicines, here’s how the US Pharmacopeia is promoting testing for DEG and EG.

Business & Regulation Advanced Medicine

Changing Regulation Around ATMPs in Europe

| Jamie Irvine | 4 min read

Preparing for the EU’s new HTA regulation and Joint Clinical Assessment process

Business & Regulation Standards & Regulation

Saying Farewell to the Famous Horse Tweet

| Stephanie Vine | 5 min read

Why the FDA must delete its statement that people are not horses (or cows), referring to ivermectin use

Manufacture Advanced Medicine

Introducing a Regulatory Playbook for Gene Therapy

| Stephanie Vine

In this video interview, Courtney Silverthorn explains the inspiration behind a free regulatory playbook for gene therapy manufacturers.

Business & Regulation Standards & Regulation

FDA Warning Letters: April 2024 Edition

| Stephanie Vine | 6 min read

Production records written using erasable markers, use of expired raw materials, and more.

Business & Regulation Standards & Regulation

Showdown Over the Abortion Pill in the US

| Stephanie Vine | 4 min read

The Supreme Court will decide the fate of the abortion pill mifepristone in the US on March 26, 2024.

Discovery & Development Ingredients

DEG Contamination: We Must Keep Eyes on Supply

| Stephanie Vine | 10 min read

As incidents of DEG poisoning continue to occur, the IPEC Federation issues a call for companies not to be complacent when it comes to supply chains.

Business & Regulation Standards & Regulation

The Device Is Right

| Hilde Viroux | 5 min read

Three regulatory pathways for drug–device combinations – and why early action is key.

Manufacture Quality & Compliance

The AMR Certificate

| Jamie Irvine | 5 min read

Introducing the British Standards Institution’s new environmental initiative to minimize antimicrobial resistance caused by manufacturing operations.


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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