Search Results for Superiority

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Patients Not Always Informed of Study's Purpose in Noninferiority Trials By Michael Mezher - Published 23 August 2017

A study published in JAMA Internal Medicine this week finds that patients participating in noninferiority trials for antibiotics are not always accurately informed of the purpose of the study, based on an analysis of informed consent forms.

Categories: News, EMA, FDA, Clinical, Drugs, Ethics

Tags: Noninferiority, Superiority, Antibiotics, Clinical Trials, Informed Consent

US Orphan Drug Exclusivity Criteria Clarified in Depomed Court Decision By Alan Minsk, JD - Published 04 December 2014

Key points and observations about a recent federal court decision on orphan drug exclusivity as outlined in the case of Depomed v. US. The central issue concerned what conditions a drug must satisfy to qualify for marketing exclusivity.

Categories: Features, US, Generic drugs, Orphan products

Tags: Depomed v US, orphan drugs, Neurontin, Gralise, post-herpetic neuralgia, exclusivity, clinical superiority

Implied Claims of Superiority Lead to Untitled Letter for Pharma Company By Alexander Gaffney, RAC - Published 19 September 2014

The US Food and Drug Administration (FDA) has sent a warning to Cipher Pharmaceuticals over an email marketing piece sent by the company to promote its cholesterol drug Lipofen, saying the piece over-stated the drug's effectiveness.

Categories: News, US, CDER, Drugs, Labeling

Tags: OPDP, Untitled Letter, Misbranding, Superiority