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The FDA is proposing a voluntary program to speed the approval of medical technologies that address unmet needs for life-threatening and irreversibly debilitating diseases. Read More
Drugmakers providing postmarket benefit-risk assessments to Health Canada will soon need to follow rigid, standardized guidelines that provide both preapproval and postapproval data about a drug’s efficacy. Read More
Drugmakers and nonprofit collaborators are releasing results from failed cancer trials so that investigators can search the datasets for signals or other useful information that may suggest new research directions. Read More
The UK’s Health Research Authority hopes to reduce the number of failed clinical trials by helping drugmakers do a better job justifying their trial designs and protocol assumptions early on. Read More
Sponsors are praising the FDA’s efforts to loosen restrictions on trials for drugs that treat community-acquired bacterial pneumonia, but want clarification on what the agency expects to see for efficacy endpoints. Read More
Drugmakers could be hit with huge medical bills for patients harmed during clinical trials, if proposed reforms to India’s drug laws are adopted. Read More
House lawmakers are seeking new ways to streamline the drug development and approval process, calling for solutions to reverse high costs of clinical trials and the slow supplemental application pathway. Read More
EU regulators are urging manufacturers of biosimilar insulin-containing products to demonstrate similar pharmacokinetic and pharmacodynamic (PD) profiles as the gold standard in proving efficacy similarity to the reference products. Read More
The European Medicines Agency (EMA) is recommending clinical trial sponsors evaluate local tolerance of medicinal products — i.e., both the active substance and excipient — at contact sites of the body as part of a clinical trial’s general toxicity studies, according to new draft guidance. Read More
The European Medicines Agency (EMA) is considering new trial designs using pathologic complete response (pCR) as an endpoint in neoadjuvant breast cancer studies for patients with aggressive, early stage breast cancer. Read More
The FDA plans to release a document later this year that will explain how devicemakers can use the agency’s benefit-risk framework for device approval when designing different types of clinical trials, CDRH Director Jeffrey Shuren said Wednesday. Read More
OncoGenex Pharmaceuticals Wednesday said the FDA has granted fast-track designation for the drugmaker’s investigational drug custirsen as a second line treatment for men with metastatic castrate-resistant prostate cancer (CRPC) and non-small cell lung cancer. Read More