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Standards & Regulation

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?

Business & Regulation Standards & Regulation

Another Year of Innovation

| Stephanie Vine

A video tour of the top FDA approvals from 2023

Business & Regulation Quality & Compliance

The FDA Investigates T-Cell Malignancies in CAR-T Therapy

| Jamie Irvine | 4 min read

The details and reactions behind a recent FDA investigation into the cancer-risk of CAR-T therapies


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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