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

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

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

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

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

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 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

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 wrangling over trial design guidance for gene/cell therapies will extend into next year as the FDA tries to satisfy industry concerns about how elements of the trials can be standardized. Read More

Drugmakers are pushing back on proposed EU GMP requirements that would expand safeguards against product cross-contamination, saying the proposed six-month timeline for implementation is unworkable. Read More