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Drug Safety

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Latest From Drug Safety

Enhanced EudraVigilance System Goes Live, EMA Updates Info For Users

After months of preparations, the European Medicines Agency’s improved pharmacovigilance database has gone live on schedule.

Drug Safety Post Market Regulation & Studies

Public Citizen Asks US FDA To Ban Olmesartan Hypertension Medicines

Given risk of serious gastrointestinal disorder, Public Citizen argues there is no reason to keep the drugs on the market when so many alternative treatments are available

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BioPharmaceutical Regulation

US FDA Gives Sponsors Some Leeway In Studying Drug Effects On Driving

Final guidance on evaluating drug effects on ability to operate a motor vehicle has been slightly modified in response to suggestions by Eisai, Pfizer and Merck.

Drug Safety Neurology

EpiPen 'Failures': More Bad Headlines For Mylan – And Reminder Of FDA's Own Risks

Latest headlines about EpiPen cite deaths associated with product 'failures.' The attention is probably unfair, given the source (US FDA adverse event reports) but it is also inevitable given the history – and may be a warning of headlines to come if and when a generic is approved.

Inflammation Generic Drugs

REMS Barriers: US FDA Takes 'Foundational Step' To Improve Generic Access

Generic firms might be able to purchase branded drugs for bioequivalence studies from Europe under concepts that FDA is considering. Commissioner Gottlieb says FDA may allow generic firms to seek wavier of shared REMS to avoid protracted negotiations. 

Generic Drugs Drug Safety

New EU Restrictions On Biogen’s MS Drug Zinbryta Are ‘Damaging’, Analyst Warns

Biogen is to continue to work closely with the EMA on clear guidance on how to use its MS drug Zinbryta, after the regulators recommended further restrictions on the product’s use because of the risk of liver damage. But an analyst says the restrictions are detrimental for the drug.

Drug Safety Post Market Regulation & Studies

Buprenorphine Injectable Opioid Abuse Treatment: Will REMS Prevent Misuse?

US FDA worries Indivior's formulation in prefilled syringes could lead to adverse events if patients obtain direct access; advisory committee to consider if REMS requiring administration by healthcare providers is adequate.

Advisory Committees Drug Safety

Making OTC Topical Drugs In Kitchen Stirs Up Problems For Oregon Firm

FDA expects Pain Relief Naturally to recall lidocaine-containing hemorrhoid, bed sore and pre-tattoo lotions and sprays. In addition to GMP problems, formulations and labeling for Naturally Healthy Living brand products are noncompliant with US FDA's for external analgesic OTC monograph and other agency rules.

Consumer Regulation

Rx Drug Ads: Number Of Side Effects, Price-Comparison Claims Impact Risk Perception

Commercials citing non-severe side effects dilute message, London study concludes; US FDA finds price comparison claims may cause physicians to think a drug's risks are less severe and that risk info is less prominent on mobile devices.

Advertising, Marketing & Sales Drug Safety
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