Drugs

FDA Planning Pregnancy Exposure Registry Study

FDA is soliciting public comment on a proposed study of healthcare providers’ perceived barriers to sufficient patient enrollment in pregnancy exposure registries. A Federal Register notice says human pregnancy safety data are collected post-approval to ensure that pregnancy information in product labeling is accurately communicated to healthcare providers (HCPs) so they can make informed decisions about treatment options for their patients.

The proposed study would involve primary HCPs (obstetrician/gynecologists, family practice physicians, certified nurse midwives, physician assistants); consulting HCPs (neurologists, infectious disease specialists, psychiatrists, rheumatologists, cardiologists, dermatologists, and pulmonologists); and pharmacists.

The research questions FDA is proposing are:

the proportion of HCPs that know about pregnancy exposure registries;
the proportion of HCPs that have referred patients to pregnancy exposure registries;
the proportion of HCPs that have provided information from patient medical records to pregnancy exposure registries;
the barriers to patient enrollment in pregnancy exposure registries identified by HCPs; and
the ideas HCPs have to increase enrollment in pregnancy exposure registries.

FDA says its goal is to have 400 completed surveys, and it estimates that HCPs will need 17 minutes to complete the online survey.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome