Simplifying Global Compliance
Indian authorities want clinical trial sites accredited and more heavily regulated. In a new report, a panel of advisors to the Ministry of Health and Family Welfare spells out specific reforms aimed at addressing past weaknesses in the country’s clinical investigation and drug approval processes. Read More
The European Medicines Agency may postpone a trial transparency initiative that was scheduled to take effect Jan. 1, 2014, due to an overwhelming number of comments from stakeholders. 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
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
Swiss drugmaker Roche plans to partner with Swiss-owned Polyphor to develop a drug that targets a leading cause of hospital-borne 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
An effort to foster better communication between the FDA’s drug and device centers is starting to pay off, with fewer requests for duplicate data on companion diagnostic submissions. 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
In a new “sunshine” bid, Britain’s brand drugmakers will begin disclosing payments made to physicians in connection with the development or sale of medicines, beginning in 2016. 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
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
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