July 14, 2020: Based on the data discussed today, it is difficult to determine how well Belantamab Mafodotin works and whether its effect is clinically meaningful. To approve a treatment for which the benefits do not clearly outweigh the risks creates additional risk for those who are already suffering.
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Women with Breast Implants Should Not Need to Wait for Safety Information They Urgently Need
Our Bodies, Ourselves, July 1, 2020. In response to the demands of thousands of breast implant patients, the FDA proposed that a black box warning be affixed to all implant packages to inform women and their doctors about the most serious risks of breast implants.
Read More »NCHR’s Testimony to FDA on Pediatric Development Plans for Oncology Indications
When evaluating drugs for pediatric use, doses must be scrutinized cautiously for children of different ages and weights. Even when there are likely benefits for children on average, it is important to minimize risks whenever possible by determining which children are most and least likely to benefit.
Read More »CRS: Congress Can Rein In FDA’s Flexible COVID-19 Vaccine Trial Policies
Inside Health Policy, June 03, 2020. The Congressional Research Service says Congress could rein in FDA’s COVID-19 policies by passing a law, and NCHR explains why that is a good idea.
Read More »Allergan is trying to track down women with breast implants it recalled nearly a year ago
Fortune, June 3, 2020. Allergan has asked small nonprofit organizations to help inform tens of thousands of women that they have a type of breast implant that has been recalled due to increased cancer risks.
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