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Five Lessons Learned About Antimicrobial Stewardship Metrics

IDStewardship

It may be derived from work completed inthe microbiology lab, unitsdispensed from the pharmacy, administrations performed by nurses, expenditures produced from drug purchases, documentation within any area of the electronic medical record, extraction from supplemental tools or data warehouses, and so much more.

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STAT+: Pharmalittle: Woodcock to retire from the FDA; Acrotech urged to speed up confirmatory study of cancer drugs

STAT

They were approved under the FDA accelerated pathway in 2009 and 2014, respectively, for treating a rare form of blood cancer. The  The company’s final study plan was submitted to the FDA in 2022 and is expected to be completed  by 2030 , according to FDA briefing documents published earlier this week.

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Increasing patient engagement with UK clinical trials

pharmaphorum

Keith Wilson is a former heart patient who has worked on a voluntary basis, over many years with various organisations and researchers, promoting Public and Patient involvement to enhance the clarity of documentation and participation in Research. Embedding the patient voice not only in research, but everything they do.

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Biogen agrees to pay $900 million in largest FCA Settlement Ever Secured without Government’s Intervention

The FDA Law Blog

Mr. Bawduniak alleged that, between 2009 and 2014, Biogen paid illegal kickbacks to its largest prescribers to induce them to prescribe the company’s multiple sclerosis drugs, Avonex, Tysabri and Tecfidera, and discourage them from prescribing newer competitor products. This lawsuit was brought to the U.S. See United States ex rel.

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ISPE’s Regulatory Commenting Process

ISPE

After a thorough internal review, health authorities sometime release a document for public comment. Regulations, draft guidance, and other documents may be requested for public comment. ISPE utilizes its members' expertise and knowledge to provide official comments on government documents. Know the key topics.

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The 20 Key Moments in the 340B Program's 30-Year History

Omnicell

The investigation, which included inquiries requesting large amounts of documents and communications from various stakeholders, is largely perceived as a drug industry-friendly fact-finding exercise. 2014: HRSA considered publishing a regulation that would have narrowed the definition of patient and placed other restrictions on the program.

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Oxford Nanopore makes stellar debut on UK stock market

pharmaphorum

The debut – raising upwards of £350 million from new shares – is the largest IPO for a UK biotech company since allergy drug specialist Circassia in 2014. It may also use the cash injection for “in-licensing opportunities and potential acquisitions”, according to the document.