• Magazine
  • ENEWS
  • SUBSCRIBE
  • WEBINARS
  • PODCASTS
  • EBOOKS
  • Home >
  • Compliance

    • 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
    microsoftteamsimage_9

    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
    PM2204-HERO-880x500-Automation

    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
    2021-FDA-approvals

    FDA year in review: 50 novel drug approvals and more

    First-in-class and orphan drugs dominated the agency's 2021 approvals
    Industry-dose-12

    The fallout from Aduhelm

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

    Adapting to Brexit in the pharma industry

    Exploring the impact of Brexit on UK pharma supply chain
    PM2111-HERO-575x327-Operations

    Leave no CMC stone unturned

    Building a CMC strategy for biologics is a critical, multistep process
    PM2110-HERO-575x327-CoverStory2

    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.
    australia

    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.