Eman Al-Hassan

Jan 14, 2025 | jdsupra.com | Eman Al-Hassan |Robert Church |Heidi Forster Gertner

FDA defines a protocol deviation as a “generally unintentional” departure from IRB-approved protocol, noting they are commonly not discovered until after they occur. For example, an investigator’s failure to perform a protocol-required test being discovered by the study monitor during a routine monitoring visit would be a protocol deviation.

Nov 14, 2024 | jdsupra.com | Eman Al-Hassan |Sanchita Bose |Robert Church

November 14, 2024 Eman Al-Hassan, Sanchita Bose, Robert Church, Heidi Forster Gertner, Ashley Grey, Blake Wilson Hogan Lovells + Follow x Following x Following - Unfollow Contact To embed, copy and paste the code into your website or blog: [co-author: Lauren Massie, Evelyn Tsisin] The U.S. Food and Drug Administration (FDA) recently held a Patient Engagement Advisory Committee meeting focused on clinical trial informed consent practices. Below, we summarize key takeaways from the meeting,...

Apr 22, 2024 | jdsupra.com | Eman Al-Hassan |Robert Church |Heidi Forster Gertner

The C3TI demonstration program is an excellent opportunity for pharmaceutical and biotechnology companies to closely interact with FDA and have meaningful input into the agency’s policy-making on clinical trial innovation. As such, we strongly encourage our clients to consider applying for this program.

Aug 22, 2023 | jdsupra.com | Stephanie Agu |Eman Al-Hassan |Deborah Cho

FDA regulations require clinical trial sponsors to present information from premarket studies on the safety and effectiveness of drugs and biologics in terms of gender, age, and racial subgroups. However, if certain patient populations are not adequately represented in premarket clinical trials, FDA may also require or request collection of such data in the postmarketing setting.

Aug 21, 2023 | lexology.com | Robert Church |Heidi Forster Gertner |Eman Al-Hassan |Deborah Cho |Stephanie Agu

Continuing the trend over the past few years to promote diversity in clinical trials, the U.S. Food and Drug Administration (FDA) has published new draft guidance on “Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products,” which describes strategies that clinical trial sponsors can utilize post-approval to enhance safety and efficacy data for populations that may have been underrepresented in premarket studies.