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Standards & Regulation

Business & Regulation Standards & Regulation

How to Avoid FDA Warning Letters

| Stephanie Vine | 3 min read

It’s relatively simple: Follow cGMP, keep your facilities clean, keep vermin out, and don’t sell unapproved products…

Business & Regulation Trends & Forecasts

Chasing Harmony

| Angus Stewart | 8 min read

An inside view of the pharmaceutical industry in China. Where has it been, where does it stand, and where is it going?

Business & Regulation COVID-19

From COVID-19 to Monkeypox

| Stephanie Vine

It’s been a busy time for infectious disease vaccine news in Europe.

Business & Regulation Standards & Regulation

Quick-Fire Q&A: Biosimilars in the US

| Stephanie Vine | 3 min read

Biosimilars have been available in Europe for years. Is the US still lagging behind?

Manufacture Biosimilars

Towards Better Biosimilar Access

| Maryam Mahdi | 4 min read

Though in theory, biosimilars should help improve medicines access, what challenges still stand in the way of therapeutic equality and equity?

Business & Regulation Business Practice

Moderna Begins New Search for Chief Financial Officer

| Stephanie Vine

Moderna’s new CFO lasts one day in the job as investigation comes to light.

Business & Regulation Standards & Regulation

Medicare Reveals Coverage Policy for Amyloid mAbs

| Stephanie Vine

Medicare publishes policy for amyloid mAbs and Alzheimer’s disease. It’s not good news for Aduhelm.

Business & Regulation Standards & Regulation

Sharing is Caring (for Animals)

| Stephanie Vine

How an initiative from EFPIA and a new public database on chemical substances could reduce animal experiments.

Business & Regulation Technology and Equipment

The 360 Virtual Tour

| Stephanie Vine

We find out how technology is enabling remote inspections in the pharma industry.

Manufacture Facilities

Embracing the Quality Mindset

| Mike Martin

With the FDA still behind on inspections, manufacturers need to uncover their own blindspots.

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