Adverse Events Reporting
The regulator cited inconsistencies with how safety trial data was recorded in a report released ahead of the advisory committee's meeting on Wednesday.
The company "embraces" adverse-event reporting and knows not to expect monetary ROI from unbranded initiatives, says its US-based social media lead.
Study shows Merck's Januvia does not increase heart risks; a former Genentech exec launches a behavioral health business; lawmakers want black-box warnings on more opioids
Novartis is apologizing to Japan after the Ministry of Health, Labor and Welfare said the company had dragged its feet reporting adverse events for two of its cancer drugs.
Last week, the former FDA branch chief who originally approved LASIK machines asked FDA to reconsider its denial last month of his petition to ban these devices.
The drugmaker has told global regulators it failed to share 10,000 reported cases of side effects for a variety of its drugs.
The regulator's proposed database could help identify adverse events.
The drugmaker's latest financial plans could power it through mid-2015.
The company announced the layoffs Friday.
Execs unveiled 10% sales growth and told investors the safety news does not implicate their just-approved MS pill.
Phase III findings on sofosbuvir, released in a medical journal, suggest no cause for concern from a safety perspective.
GSK's Avandia woes continue, study finds a new way to identify adverse events, and Royalty ups its bid for Elan.
Business briefs: Reps mum on adverse events; FCC's new mHealth director; med schools tighten speaking limitsApril 11, 2013
A study finds sales reps find time to talk benefits, but not risks, even when touting black-box drugs; FCC has named its new mHealth director; pharma scaled back its food budgets last year; and AMSA says 18 med schools now ban faculty from speakers bureau participation
A study linking higher levels of hospitalizing pancreatitis among Januvia and Byetta patients has not caused a patient backlash.
FDA issues may deter drugmakers from engaging in social media, but that's no excuse to ignore what audiences are saying on these platforms, say pharma and device firms.
Drug companies are putting their in-house medical staffs on call for prescribers to ask product-related questions or report adverse events via smartphone.
Pfizer is experimenting with electronic medical records and mobile technology to detect safety issues sooner.