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Standards & Regulation

Business & Regulation Business Practice

GDUFA 2020

| Stephanie Sutton

GDUFA fees for 2020 have been decided – and include a significant drop in the fees for finished dosage facilities.

Business & Regulation Business Practice

Perpetual Preparedness

| James Strachan

With a no-deal Brexit still a real possibility, Merck continues to prepare for the worst case scenario.

Business & Regulation Clinical Trials

Brexit Realities

| James Strachan

Our animation explores the unique challenges a "no-deal" Brexit poses for the drug development and advanced therapy sectors.

Manufacture Standards & Regulation

Quality, Not Quantity

| Iain Moore

Qualitative risk assessments are a great way to approach quality management and train your operators at the same time.

Business & Regulation Small Molecules

And for 2020...

| Stephanie Sutton

Nominations are now open for The Medicine Maker 2020 Power List.

Manufacture Standards & Regulation

A Continuous Cycle of Success

| David Thompson

Helping to meet demands and reduce shortages... Is continuous manufacturing the way forward for pharma?

Business & Regulation Standards & Regulation

The IPEC Story: Promoting Ingredients for Success

| With David Schoneker

High quality excipients make all the difference to the drug development process. And yet, for years, excipients were often overlooked by the industry.

Business & Regulation Standards & Regulation

Cutting Out the Middleman

| Maryam Mahdi

What are the consequences of allowing patients to purchase cell and gene therapies directly from hospitals?

Business & Regulation Contract Manufacturing Services

(Block)chain Reaction

| Heather Zenk

Blockchain could be one solution to the saleable returns verification aspect of the US’ Drug Supply Chain Security Act.

Business & Regulation Standards & Regulation

So Long and Thanks for all the Drugs

| Stephanie Sutton

Scott Gottlieb prepares to leave the FDA after accomplishing much.

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