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Standards & Regulation

Business & Regulation Advanced Medicine

2021 in Review: Our Best Videos

| Angus Stewart

Panels, thought leaders, and spicy opinions! Here’s a roundup of our best video content of 2021.

Business & Regulation Digital Technologies

Why We Need Patient-Centric Pharmacovigilance

| Saba Darvesh

Can digital approaches help improve pharmacovigilance practices?

Business & Regulation Standards & Regulation

The Sacred Texts

| Sue Batchelor

New ICH guideline revisions are imminent. Sue Batchelor of Cmed shares her thoughts on how sponsors and CROs can prepare themselves.

Business & Regulation Technology and Equipment

FDA Authorizes VR for Pain Reduction

| Stephanie Vine

AppliedVR gets FDA OK to market virtual reality system for chronic pain.

Business & Regulation Standards & Regulation

Will it Really Be Built Back Better?

| Stephanie Vine

A quick look at reactions across the US to Biden’s Build Back Better bill.

Business & Regulation COVID-19

R&R for an Anti-COVID Europe

| Angus Stewart

The EMA has given the nod to Ronapreve and Regkirona, two monoclonal antibody treatments for COVID-19.

Business & Regulation Standards & Regulation

Lobby and Legislature Play Pricing Plan Ping Pong

| Angus Stewart

After a madcap back and forth between leading and dissenting Democrats, Biden’s drug pricing reform plans have reached a compromised final form.

Business & Regulation Biosimilars

A Warm Welcome to Biosimilars

| Stephanie Vine

The FDA has approved just three biosimilars in 2021 – but the approvals could shake up the field as discussions around interchangeability intensify.

Business & Regulation Standards & Regulation

The Return of Robert Califf

| Stephanie Vine

After nine months of speculation about who will be the next FDA commissioner, we may finally be close to a decision.

Business & Regulation Standards & Regulation

The Price Ain’t Right

| Angus Stewart

We speak with the authors of two studies into extreme increases in US drug pricing, and attempts by lawmakers to bring the price-jackers into line.

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