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85 Total results for product and free and sample content found

Scrip: 世界の医療用医薬品&製薬産業に関するニュース

An AdComm After All: Amarin's Vascepa Labeling Update Now Delayed By FDA

15 Aug 2019

The US FDA informed the company it will convene an advisory committee meeting to review the REDUCE-IT sNDA for the proprietary fish oil pill, delaying the approval by at least three months and surprising investors.

Topic fda drug-approval

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

The Stakes Are High So Get It Right: CHMP Oral Explanations & FDA AdComs

09 Aug 2019

The stakes are extremely high for companies called before EU or US regulators and scientific experts to answer queries about their new drug applications at the later stages of the review process. How they perform is critical. Consultant Kate Dion has a raft of helpful tips for companies facing this daunting situation. Neena Brizmohun reports.

Topic Drug approval

Scrip: 世界の医療用医薬品&製薬産業に関するニュース

UK Committee Attacks Pharma Over Lack Of Medicinal Cannabis Research

By Ian Schofield 12 Jul 2019

The pharmaceutical industry has come under attack by a UK parliament committee for failing to make medicinal cannabis products available for clinical trials, saying that a "robust research base" is needed on which to base future treatment decisions.

Topic clinical-trials drug-approval

Cannabidiol - HBW Insight coverage

10 Jul 2019

Cannabidiol (CBD) is being looked at more and more by health beauty and wellness companies for new OTC drugs, cosmetics and supplements. It is highly controversial because while CBD has many natural benefits for treating a variety of symptoms and conditions, it is the active ingredient in cannabis which comes from the hemp plant.

Topic drug-review drug-approval

European CBD Market Snapshot: UK Leads As Retailers Get On Board With FSA Decision Pending

05 Jul 2019

The UK's cannabidiol market, which according to the Cannabis Trades Association is the largest in Europe, awaits clarification on the legal status of CBD-containing food supplements. Meanwhile, major retailers like Walgreen Boots Alliance are stepping into the space with branded products.

Topic policy-and-regulation strategy drug-approval

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

Romosozumab Among Latest Drugs Up For CHMP Opinion

By Vibha Sharma 04 Jul 2019

Four drugs are up for an opinion this week on whether they should be granted EU-wide approval, including Amgen/UCB's osteoporosis drug romosozumab.

Topic drug-approval policy-and-regulation

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

Will US Government Pursue Fewer False Claims Act Cases In 2019

By Brenda Sandburg 03 Jul 2019

Fallout from Supreme Court's Escobar decision and Department of Justice memos could impact types of healthcare fraud complaints in which the government intervenes.

Topic Drug approval Strategy

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

US Initiative To End HIV Epidemic Will Boost PrEP Access

03 Jul 2019

'Number of different initiatives' coming in next several months to make drugs more affordable, including for PrEP prophylaxis, HHS Assistant Secretary for Health Giroir says. Multi-agency approach is key strategy.

Topic drug-approval drug-development-landscape drug-review

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