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Standards & Regulation

Business & Regulation Standards & Regulation

Sitting Down With… The Past: Bruno Sepodes

| Jamie Irvine

We dive into the archive of 2018 for insight and inspiration – this time with Bruno Sepodes

Business & Regulation Supply Chain

Fighting the Pirates: The Rising Threat of Counterfeits

Counterfeit medicines pose a significant threat to global health. A recent study uncovers alarming facts and emphasizes the need for solutions.

Discovery & Development Drug Discovery

Addressing the Empire of Pain

| Jamie Irvine | 11 min read

How the pharma industry can help tackle the opioid crisis and advance treatments

Business & Regulation Standards & Regulation

FDA Warning Letters: September 2024 Edition

| Stephanie Vine | 3 min read

Here’s a look at recent violations cited in FDA Warning Letters: fly pupae, cross contamination, trial dosing errors, and more.

Business & Regulation Business Practice

Driving the Future of Biopharma

| Rob Coker

Biopharma companies procrastinating on sustainability measures risk falling behind, according to Cytiva’ Global Biopharma Sustainability Review.

Business & Regulation Standards & Regulation

AstraZeneca Flu Vaccine Approved For Self-Administration

| Rob Coker

AstraZeneca’s FluMist is the first flu vaccine to be approved for self-administration.

Business & Regulation Standards & Regulation

The Demands and Ethical Obligations of the DSCSA

| Matt Sample, Gregg Gorniak | 3 min read

The deadline for the US Drug Supply Chain Security Act is approaching.

Business & Regulation Supply Chain

Where Have All the Drugs Gone?

| 6 min read

Drug shortages are everywhere. We speak with Vimala Raghavendran at the US Pharmacopeia to get the full picture.

Business & Regulation Business Practice

Why Pharma Must Embrace AI and Open Source

| Brendan Frey | 4 min read

With open minds and open sources, the future is foundational – and bright.

Business & Regulation Standards & Regulation

EMA: No to Lecanemab

| Stephanie Vine | 3 min read

Lecanemab is refused marketing authorization by the European Medicines Agency.


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

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