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Drug Safety

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Latest From Drug Safety

Opioid Indications Under TGA Scrutiny As Australia Tackles Growing Misuse

The Australian drug regulator is reviewing the indications, pack sizes and information documents for consumers of potent opioid products to see how misuse and overdoses can be prevented.
Australia Drug Safety

Novo Nordisk CEO Says Group Doubling Medical Supplies in UK Ahead Of Brexit

Novo Nordisk's chief says the Danish company is stockpiling medicines in case of "no deal" hard Brexit

Brexit Business Strategies

Opioid REMS Increases Nearly Six-Fold As US FDA Adds Immediate-Release Products

Basically every doctor prescribing any opioid is now covered by the REMS, but training remains voluntary. 
Risk Management Neurology

US FDA May Change Requirements For CV Outcomes Trials For Type 2 Diabetes Drugs

Endocrinologic and Metabolic Drugs Advisory Committee will reconsider 2008 guidance on evaluating CV risks in antidiabetic therapies at two-day meeting in October.

Advisory Committees Metabolic Disorders

US FDA Reviews IBS-C Candidates Both New (Tenapanor) And Old (Tegaserod)

Ardelyx touts tenapanor's novel mechanism, favorable safety profile; advisory committee announcement reveals US Worldmeds’ bid to revive Novartis’ withdrawn Zelnorm.
Drug Review Gastrointestinal

Another Nitrosamine Impurity Found In Valsartan; ‘Low’ Cancer Risk Seen

Zhejiang Huahai has detected a second probable carcinogen in valsartan API it manufactured. Meanwhile risk analysis suggests cancer risk from the first probable carcinogen is low, at least so far.

Manufacturing Quality

Topical Drug Products: US FDA, Experts Tackle Challenges Of Dermal Safety Studies

29 Rx drug products have dermal safety study results in their labeling; workshop panelists cite need for sponsors to finalize formulations earlier.

FDA Drug Safety

EMA Postpones Decision On Next Phase Of EudraVigilance To End Of 2019

The European Commission has agreed to extend the ongoing signal detection pilot involving the revamped EU pharmacovigilance database and has asked for a report on experience in the first year. 
Europe Drug Safety

‘Triple S’ Project To Strengthen Drug Safety Monitoring In Lower-Income Countries

A new global project is being set up to help low- and middle-income countries establish pharmacovigilance systems that will allow them to manage safety issues with new drugs for diseases like malaria and TB.
Drug Safety Emerging Markets
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