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