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Standards & Regulation

Business & Regulation Standards & Regulation

Is the FDA About to Break?

| Stephanie Vine | 3 min read

Job cuts at the FDA spark concern, with Robert Califf saying the agency as we know it is “finished.”

Business & Regulation Standards & Regulation

Sitting Down With… The Past: Peter Marks

| 3 min read

We dive into the archive of 2021 for insight and inspiration – this time with Peter Marks

Business & Regulation Business Practice

The Trump Effect on Cell and Gene: Science versus Shockwaves

| 9 min read

Audrey Greenberg on FDA staffing cuts, Peter Marks’ resignation, CDMO pressure, IP migration, AI acceleration, and what CGT needs now to stay on track

Business & Regulation Standards & Regulation

Vaccines and Autism: Perpetuating a Populist Agenda

| Rob Coker | 3 min read

Rumours claim that a well-known vaccine skeptic has been appointed to lead study on links between vaccines and autism.

Business & Regulation Standards & Regulation

Peter Marks Resigns from FDA

| Stephanie Vine | 3 min read

Resignation letter states: “truth and transparency” around vaccines are not desired by Health Secretary RJK Jr.

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

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