Drug Product Recalls In 2011: Categorized By Problem Area

This table lists every drug recall of 2011, along with a description of the drug product, the manufacturer, the recaller, the recall class and the reason for the recall.

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Pharma Exhales, Dodges Financial Blow With Tariff Exemption

 

Industry lobbing for pharmaceuticals to be exempt from President Trump’s sweeping US tariffs appears to have paid off.

Will They Or Won’t They? Tariff Questions Loom For Drugmakers

 

Pharma executives and investors are waiting with bated breath to find out if President Trump will include drugs in a new round of tariffs to be announced on 2 April.

Gene Therapy ‘Survival Of The Fittest’ – Why Companies Need To Understand Health Systems

 

Cell and gene therapy manufacturers must consider the practicalities of their product within the context of a health care system before it comes onto the market to be successful, experts from Novartis, AstraZeneca and England’s National Health Service say.

Global Pilot Reduces Drug Manufacturing Inspections With Hybrid Approach

 
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A global collaborative inspections pilot reduced the number of individual inspections for participating manufacturing facilities, demonstrating that multiple regulatory authorities can carry out joint inspections using a mix of on-site and remote approaches.

More from Compliance

US FDA Cites Taiho’s Lytgobi Healthcare Provider Website For Misleading Efficacy Claims

 
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Results from a single-arm study cannot support representations on overall survival, progression-free survival and disease control rate for the cancer drug, the Office of Prescription Drug Promotion said in another “untitled” letter implicating the agency’s CFL guidance.

Gene Therapy ‘Survival Of The Fittest’ – Why Companies Need To Understand Health Systems

 

Cell and gene therapy manufacturers must consider the practicalities of their product within the context of a health care system before it comes onto the market to be successful, experts from Novartis, AstraZeneca and England’s National Health Service say.

Global Pilot Reduces Drug Manufacturing Inspections With Hybrid Approach

 
• By 

A global collaborative inspections pilot reduced the number of individual inspections for participating manufacturing facilities, demonstrating that multiple regulatory authorities can carry out joint inspections using a mix of on-site and remote approaches.