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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

Anticipating AI regulations in pharma manufacturing

In a rapidly evolving regulatory landscape, leaders should remain ready to adapt to new legislation

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

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

The company is in trouble after failing to submit clinical trial results for its phase 3 study of eye drops for patients with dry eye disease

Supporting continued process verification

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

FDA shares gene therapy research guidance

Through a recommendations draft issued earlier this week, the agency discussed the present and future of gene-editing studies

News

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

Pfizer cancer drug now comes with a warranty

In hot water with the FDA, Teva halts production at Calif. plant

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

Legal unease

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

FDA says it won’t accept data from two CROs in India

The FDA recently issued a notice to pharma companies that drug applications with data from two clinical research organizations will no longer be acceptable.

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...

The battle over boosters deepens

The published review is the latest twist in an ongoing battle over boosters between the FDA, CDC and the White House.

Bausch drops $300M to settle diabetes drug suit

Bausch Health Companies has agreed to pay $300 million to settle an antitrust suit linked to an 800% price hike for a diabetes drug.

EU says AstraZeneca’s vax can trigger rare nerve disorder

Europe’s medicine regulator has listed a very rare nerve-damaging disorder as a possible side-effect of AstraZeneca’s COVID-19 vaccine.

FDA slaps blockbuster JAK inhibitors with new safety warnings