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Cosmo Technologies filed a second lawsuit against Actavis alleging the drugmaker infringed upon Cosmo’s patent with its newly approved generic for the colitis drug Uceris (budesonide). Read More
The FDA issued an untitled letter to Arog Pharmaceuticals for promotional claims it made on a display booth and a webpage about an unapproved investigational new drug’s safety and efficacy. Read More
The Justice Department issued a final rule Wednesday that will strengthen the Drug Enforcement Administration’s ability to crack down on drug diversion. Read More
The FDA unveiled six new draft guidances outlining its latest thinking on the rapidly evolving field of gene therapy — and Commissioner Scott Gottlieb said the agency plans to work with product sponsors to help make the development and approval of innovative gene therapies more efficient. Read More
Americans’ trust in drugmakers plunged in the past year to the lowest level since Edelman launched its annual Trust Barometer survey five years ago. Read More
The FDA released final guidance spelling out its review goals for amendments to abbreviated new drug applications and prior approval supplements under GDUFA II. Read More
The FDA published two final guidances clarifying the information drugmakers can provide to payors and what non-label information they can communicate. Read More
After a flurry of opioid- related bills passed the House earlier last week, the chamber on Friday passed legislation that will limit the availability of synthetic drugs. Read More
The FDA released a list of alternative suggestions for complying with CGMP requirements for drug combination products that covers stability testing, release for distribution, reserve samples and special testing requirements. Read More
Representatives from the FDA and the European Medicines Agency discussed further opportunities for collaboration in their 2018 annual meeting. Read More
The European Medicines Agency proposes to merge two guidances on clinical evaluations of bacterial infection treatments to reflect the latest scientific advice from its Committee for Medicinal Products for Human Use. Read More