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PhRMA is resisting the centerpiece of the FDA’s draft guidance on antibacterial drug development, saying superiority trials for antibacterials that treat drug-resistant infections are “neither routinely possible nor consistently ethical.” Read More
While MiMedx disagrees with the FDA’s reasoning for requiring BLAs — and, hence, clinical trials — for its regenerative, human cellular and tissue-based products (HCT/Ps), the company says it will oblige the agency to set precedence for future products developed by competitors. Read More
The push for trial data transparency — by regulators and pharma alike — kept sponsors and clinical sites on their toes in 2013. Both sides agreed that more transparency is needed, but they diverged on how to accomplish the goal. India announced new standards for ethics boards and patient compensation, while Japan’s Pharmaceutical and Medical Devices Agency launched an R&D and strategy consulting arm to fine-tune the development of novel products and speed regulatory approvals. Buzz words included “personalized medicine,” “enrichment trials” and “centralized monitoring.” Use this roundup of news highlights in 2013 to plan your clinical trial strategy for the year ahead.Read More
Drugmakers could be required to submit less data for antibiotics and antifungals that affect limited patient populations if a new House bill aimed at building on the success of the Generating Antibiotics Now Act is passed into law. Read More
Generics makers should design tablets and capsules to be similar in size and shape to their reference listed drug (RLD) when they seek ANDA approval, the FDA says. Read More
Advisors to Ministry of Health and Family Welfare are calling for reforms to address weaknesses in India’s clinical investigation and medical products approval processes. Read More
The biggest hurdle when trial investigators and staff are trying to build a good relationship with a study participant is managing their expectations, experts say. But there are some basic tips sites can use to overcome those hurdles. Read More
New technology and anxiety over expiring patents have driven pharma to triple clinical development of large molecule and biologic drugs over the past decade, says an industry expert. Read More
The FDA and Vanda failed to agree on a prespecified primary endpoint for the new sleep disorder drug, tasimelteon, but that didn’t derail the company’s NDA. Read More
The FDA seems to have side-stepped many of the issues raised by industry in a draft guidance on preclinical considerations for gene/cellular therapies (CGT) while extending a guidance deadline for early-stage CGT development. Read More
Despite not agreeing on primary endpoints with the FDA before beginning clinical trials for a new sleep disorder drug, Vanda was able to get an almost unanimous recommendation from an advisory committee earlier this month. Read More