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Regulatory Guidance

Keeping up to speed with the ever-changing global regulatory environment isn’t easy, but it’s vital when it comes to ensuring ongoing compliance. This section offers discussions of new or updated guidance, regulations, and standards.

Articles

Supporting continued process verification

CPV is required for regulatory compliance but can also provide process improvements

FDA year in review: 50 novel drug approvals and more

First-in-class and orphan drugs dominated the agency's 2021 approvals

The fallout from Aduhelm

What our coverage of Biogen’s Alzheimer’s approval got right — and wrong — about the FDA’s decision

Adapting to Brexit in the pharma industry

Exploring the impact of Brexit on UK pharma supply chain

Leave no CMC stone unturned

Building a CMC strategy for biologics is a critical, multistep process

News

Ocugen could face $10,000 FDA non-compliance fine

FDA shares gene therapy research guidance

FDA hits Zydus with trio of observations

EU watchdog flags new safety concerns for J&J vaccine

Drugmakers score first 1st trial win in opioid suits

An unexpected pharma company ranked No. 1 in lobbying this summer

Legal unease

How the generics industry is adjusting as the dust settles on price-fixing lawsuits

Global Dose: Focus on Australia

While the R&D and clinical world has stayed on the cutting edge of modern medicine, the country’s manufacturing industry has slipped through the cracks of Australia’s economy...

A starting roadmap to reshoring pharma

How life sciences executives can rethink domestic drug production as part of a broader plan to reshape their global operating model

Drugs down the drain

When doctors administer treatments to patients, some amount of drug is often left behind in the vial. What happens next? It gets tossed. Now, Congress is taking a closer look ...

Taking it to the extreme

The importance of temperature, humidity and light testing for drug stability

The next phase of drug creation

Why animal models are on the brink of extinction

Winning the drug development relay

Six ways to complete handoffs and speed your company's race to the development finish line

The Alzheimer's approval maze

Navigating one of the FDA's biggest decisions of the decade

Top pharma industry predictions for 2021

In many ways, the beginning of 2021 isn’t just one of the most welcome New Years of the modern era — it could also be a turning point between the pre-COVID and post-COVID worlds...