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Finalized guidance on preclinical considerations for gene and cellular therapies, posted Monday, reiterates the agency’s position that sponsors should focus on five objectives in preclinical trials. Read More
GlaxoSmithKline said Nov. 6 that several new chemical entities identified through its novel drug discovery program, Discovery Partnerships with Academia, are close to being ready for clinical studies. Read More
Today’s regulatory culture is too risk-averse when it comes to drug approvals and risks keeping promising treatments off the market, senior officials at the European Medicines Agency say. Read More
The European Medicines Agency will accept premarket applications with limited data for antibiotics that target unmet needs, according to an amended guideline on developing antibacterial drugs for multidrug-resistant infections. Read More
To improve compliance in clinical trials, investigators need to find ways to accommodate individual patient needs and help trial participants understand the rationale behind protocols, an industry report says. Read More
Sponsors of medical device clinical trials should avoid recruiting and putting at risk an unnecessarily large number of patients, a new guidance by the UK’s Medicines and Healthcare products Regulatory Agency says. Read More
CDER Director Janet Woodcock said Nov. 15 that she supports the creation of a swift-approval pathway for antibiotics that target limited patient populations. Read More
The FDA has delayed Sarepta Therapeutics’ NDA submission for its Duchenne muscular dystrophy (DMD) drug because of a failure in trials of a similar drug. Read More
The FDA strongly recommends blinding in device pivotal trials, when possible, and notes that, even if the subject and/or the investigator cannot be blinded, devicemakers may be able to secure a blinded third-party evaluator to assess the study endpoints. Read More
Sponsors of direct-acting antiviral (DAA) drugs for the treatment of chronic hepatitis C got some relief in the form of a relaxed endpoint for use in late-stage studies. Read More
When adding a pediatric indication to a drug product, drugmakers are advised to consider a range of different pharmaceutical forms and formulations that might be more suitable for children, a draft revision to European Commission guidelines on pediatric investigation plans says. Read More
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