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Author Archives: Hazar Awad Granko

Final Rule Confirms, Posting of Study Results on ClinicalTrials.gov Will be Required for Unapproved Products

November 29, 2016 | Hazar Awad Granko, RPh, PhD, Senior Director, Regulatory Affairs | Regulatory Affairs

In a previous post, we told you about the National Institutes of Health’s (NIH) Notice of Proposed Rulemaking (NPRM) on expanded clinical trial registration and results submission on ClinicalTrials.gov. The Final Rule has now been issued and significantly expands the registration and results reporting requirements for clinical trials.

Background
The Food and Drug Administration Amendments Act of 2007 (FDAAA) required Sponsors of certain clinical trials to register on ClinicalTrials.gov, but only required results reporting for trials of drugs, biologics, or devices that were approved, licensed, or cleared by the FDA.

In a push for expanding transparency and advancement of public health, the NIH issued an NPRM in November 2014 proposing to expand these requirements. After receiving over 900 comments from various companies, organizations, and individuals, and nearly 2 years later, the NIH has now issued a Final Rule on clinical trials registration and results reporting.

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Revised Guidance Clarifies FDA’s Expectations for Formal Meetings with Sponsors

April 1, 2015 | Hazar Awad Granko, RPh, PhD, Director, Regulatory Affairs | Regulatory Affairs

The FDA has outlined certain new procedures and associated timelines for sponsors seeking formal meetings to obtain feedback and guidance from the Agency during product development and review. If you’re planning on requesting an upcoming meeting with FDA, read on to learn more about some important changes that may impact you.

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Proposed Rule Calls for Posting of Study Results on ClinicalTrials.gov, Even for Products that Aren’t Approved

March 9, 2015 | Hazar Awad Granko, RPh, PhD, Director, Regulatory Affairs | Regulatory Affairs

The National Institutes of Health (NIH) recently extended the comment period for its Notice of Proposed Rulemaking (NPRM) on expanded clinical trial registration and results submission to March 23, 2015.

This proposed rule would have a significant impact on reporting requirements for clinical studies of products that are not yet approved by FDA.

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