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

Anticipating AI regulations in pharma manufacturing

In a rapidly evolving regulatory landscape, leaders should remain ready to adapt to new legislation
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2024 pharma predictions: Regulations, sustainability and culture

In part 2 of our series, leaders weigh in on what the pharma industry can expect in the coming year
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Supporting continued process verification

CPV is required for regulatory compliance but can also provide process improvements
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FDA year in review: 50 novel drug approvals and more

First-in-class and orphan drugs dominated the agency's 2021 approvals
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The fallout from Aduhelm

What our coverage of Biogen’s Alzheimer’s approval got right — and wrong — about the FDA’s decision
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Adapting to Brexit in the pharma industry

Exploring the impact of Brexit on UK pharma supply chain
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Leave no CMC stone unturned

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

How the generics industry is adjusting as the dust settles on price-fixing lawsuits
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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...
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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
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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 ...
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Taking it to the extreme

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

Why animal models are on the brink of extinction
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Winning the drug development relay

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

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