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Par says former employees who founded QuVa used Par's trade secrets to develop a vasopressin product, which FDA has added to its list of ingredients for drug compounding.
Purdue says it conducted a trial required under the Pediatric Research Equity Act but is not seeking a formal indication and will not promote the opioid for pediatric populations. Two advisory committees will discuss the trial results and whether they support additional labeling for the buprenorphine transdermal product Sept. 13.
Biocon and partner Mylan have withdrawn the European application for their biosimilar trastuzumab and pegfilgrastim in the backdrop of compliance blips at Biocon’s Indian site, raising critical questions on how soon things can be set right in an increasingly competitive scenario.
The European pharmaceutical trade group EFPIA says an “initial pilot” program should be launched to test the value and impact of the draft EU guideline on presenting lay summaries of clinical trial results. The group believes that the guideline should be reviewed following the pilot, as complying with it in its current form would result in companies shelling out “significant additional resources.”
The EU Heads of Medicines Agencies has outlined some of the recent initiatives taken by the member states to deal with medicines shortages, including a new Dutch center and a member state coordinating initiative by the Irish regulator.
New EU guidance will help companies preparing marketing authorization applications understand what to include in Module 3 of their common technical document.
Ccompiled from the Official Gazette of the US Patent and Trademark Office, Class 3 (Cosmetics and Cleaning Preps) and Class 5 (Pharmaceuticals) marks registered and published for opposition.
The Drug Controller General of India has reissued its demand for manufacturers to comply with a new self-inspection and reporting rule and has set a deadline for them to do so.
Tomas Philipson, a University of Chicago professor and consultant to the pharmaceutical industry, is named to the White House Council of Economic Advisors.
Homeolab USA’s and Cellex-C’s imports were stopped earlier in 2017 following GMP inspections at their facilities, and FDA warns that approvals for marketing of additional products in the US could be withheld until each firm is GMP-complaint. Homeolab trips up by trying to prevent FDA photography inside plant.
The pharmaceutical industry and other stakeholders are calling for practical advice on how the new EU guideline on using a risk-proportionate approach to clinical trials will be implemented in practice. Clarity has been sought on several topics, especially on new requirements such as preparing a risk assessment and mitigation plan as part of a trial protocol.
Drugmaking is among key information infrastructure industries likely subject to additional security and reporting obligations under draft legislation, adding costs and even potentially causing business disruptions, legal experts say.
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