NCHR Testimony on Omadacycline for Skin Infections and Pneumonia

August 8, 2018. If omadacycline is no better than some drugs on the market, and may be less safe or less effective for older patients, those with more serious infections, and patients with diabetes and lung disease, it is important to conduct further studies to know whether they should be excluded from the indication or not.

Read More »

NCHR Testimony of TIRF REMS

August 3, 2018. TIRFs provide important options for cancer patients dealing with pain. However, we all know that they carry very serious risks and that’s why we need REMS that protect patients’ these risks.  These REMS are not working as well as the should to protect patients and need to be approved.

Read More »

NCHR Testimony on Nucala for Eosinophilic COPD

July 26, 2018. New products must provide a real and clinically meaningful benefit, not just a hope that the treatment works. Unfortunately, the clinical trial data presented today do not provide substantial evidence that mepolizumab [Nucala] provides this benefit for patients with COPD and high eosinophil counts.

Read More »

NCHR Testimony at FDA on Approval of Abuse-Deterrent Opioid, Remoxy

June 26, 2018: To reduce the opioid epidemic, the FDA must hold pharmaceutical companies to a high and truthful standard. Remoxy did not meet the FDA’s standards for oral abuse, and it remains unclear whether it can be abused intravenously. The safety of the excipient is also in question. Please carefully consider the risks of putting another drug with abuse-deterrent labeling on the market that could result in misuse and abuse in the real world. We urge this Advisory Committee to vote that the benefits of this drug do not outweigh its risks.

Read More »
Page 1 of 3812345...102030...Last »