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December 26, 2018
FDA sent a warning letter to Roche’s Genetech for marketing unapproved stem cell products and puts other stem cell firms and providers on notice.
December 19, 2018
Despite ongoing efforts to address drug shortages, FDA now sees a rise in active shortages and in the duration of supply problems.
December 18, 2018
The agency sent a warning letter to Cao Medical Equipment Co., Ltd. after inspectors found CGMP violations at the company’s Langfang, Hebei facility.
December 14, 2018
The UK Pharma Industry has emphasised the need for the government to avoid a 'no-deal' Brexit in response to the prime minister delaying the deal vote.
December 13, 2018
FDA has withdrawn the proposed rule that would have allowed generic-drug makers to independently update and distribute new safety information in drug labels.
December 12, 2018
New FDA guidance developed to identify lapses in data integrity and promote best practices.
FDA cites Zhejiang Huahai Pharmaceutical in valsartan impurity investigation.
December 05, 2018
The EMA has published a revision to its guideline on the environmental risk assessment of human medicines.
Shire has announced that the European Commission has granted marketing authorisation for Takhzyro (lanadelumab) subcutaneous injection.
December 03, 2018
The proposal from the Centers for Medicare and Medicaid Services (CMS) proposes to give plans more flexibility to limit coverage of certain drugs.