Subscribe to Newsletter

Standards & Regulation

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.

Discovery & Development Drug Discovery

Targeting Alopecia with Plant Power

| Saad Harti | 8 min read

A drug development story: how one company filed a marketing authorization in Europe for a botanical drug to treat alopecia areata.

Manufacture Advanced Medicine

What’s Happening with CAR T Therapies?

| Stephanie Vine | 3 min read

A look at the FDA’s safety investigation into CAR T therapeutics.

Business & Regulation Standards & Regulation

Health Canada Unhappy with Florida’s Drug Importation Plans

| Stephanie Vine | 3 min read

As the Sunshine State looks to import medicines to lower costs for Floridians, what of ongoing shortages for Canadians?


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

Sister Publications

You might be interested in our Sister Publications:

Register to The Medicine Maker

Register to access our FREE online portfolio, request the magazine in print and manage your preferences.

You will benefit from:
  • Unlimited access to ALL articles
  • News, interviews & opinions from leading industry experts
  • Receive print (and PDF) copies of The Medicine Maker magazine

Register