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Standards & Regulation

Business & Regulation Standards & Regulation

The Future of the NIH

| Hernan Bazan | 2 min read

Thoughts on the US National Institutes of Health and its role in funding research for non-opioid therapeutics.

Business & Regulation Business Practice

Calling Out Misleading Information

| Rob Coker | 2 min read

FDA letter sent to Edenbridge Pharmaceuticals demonstrates the challenges of getting pharma advertising right.

Business & Regulation Advanced Medicine

We Need to Talk About CRISPR

| 4 min read

Neal Baer, editor of a collection of essays on CRISPR, says we must not overlook the dark side of the technology.

Business & Regulation Digital Technologies

Forecasting Medicine Use and Controlling Supply Chains

| Tim Tinnel | 3 min read

The role of digital technologies in optimizing traceability in pharmaceutical supply chains.

Business & Regulation Standards & Regulation

GSK’s Flovent Strategy Under Federal Scrutiny?

| Rob Coker | 2 min read

US Senator Elizabeth Warren calls for a federal investigation into GSK and its discontinuation of Flovent HFA

Manufacture Facilities

FDA Warning Letters: March 2025 Edition

| Stephanie Vine | 3 min read

Indian CDMO denies manufacturing drug, contract testing lab pulled up for deficiencies, and lessons learned from Sanofi’s warning letter.

Business & Regulation Business Practice

Biden’s Legacy; Trump’s Agenda: Part 2

| 7 min read

In part 2 of our roundtable discussion, thought leaders discuss what Trump could do for drug pricing and whether change is to be feared or embraced.

Business & Regulation Business Practice

Biden’s Legacy; Trump’s Agenda: Part 1

| 10 min read

Biden pushed drug pricing reforms, whereas Trump is known for deregulation. What does this mean for pharma?

Business & Regulation Profession

Sitting Down With... Moncef Slaoui

| 5 min read

The career path of Moncef Slaoui has resulted in billions of doses of lifesaving vaccines. Here he shares his story.

Business & Regulation Standards & Regulation

UK Launches Seven New Centres for Regulatory Science and Innovation

| Stephanie Vine | 3 min read

A regulatory science push in the UK includes centres for digital transformation, AI and more.


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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