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The FDA provides all the GCP regulations and guidances you need to run a clinical trial, but those documents can’t answer every question you may have. Fortunately, the agency offers another resource — the staff of its Office of Good Clinical Practices. Every day, OGCP fields questions from investigators, sponsors, IRBs and other interested parties. Read More
The U.K.’s Information Commissioner’s Office published a draft guidance on obtaining informed consent, ahead of stricter European Union regulations on data protection that take effect in May 2018. Read More
An NIH center announced that all clinical trial sites participating in its grant program have agreed to use a single institutional review board for each multi-site study. Read More
Pharmaceutical companies and clinical research organizations are seeking greater clarity in an FDA draft guidance covering clinical trials with multiple endpoints. Read More
The PTO’s Patent Trial and Appeal Board upheld Shire’s patent claims — following a challenge from Green Cross — over methods for the manufacture of Elaprase (idursulfase), an enzyme replacement therapy for Hunter syndrome. Read More
Less than a month shy of mandating electronic submissions of drug and biologic master files in the eCTD format, the FDA has decided to postpone the requirement until May 2018. Read More