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Archive for ‘September, 2011’

Health Canada Announces Increased Scope of Submissions Being Accepted in eCTD Electronic-Only Filing Format

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September 30, 2011 | Posted in CMC Review Policy, Marketing Application/General, News Brief, US/Canada | Read More »

FDA Releases Report on Drug Diversion and Counterfeiting Cases

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September 29, 2011 | Posted in Anticounterfeiting, Diversion, GDP/Supply Chain, GMP Enforcement Activity, GMP Policy, General, News Brief, Region/International, Supply Chain/GDPs, US/Canada | Read More »

WHO, USP and PDA Make Substantial Contributions to GDP Guidance Canon

The international pharmaceutical community is continuing to expand and refine its guidance for good distribution practices (GDPs) to give industry the tools it needs to protect and assess product quality in the face of the many hazards of a complex global supply chain....
September 27, 2011 | Posted in CMC Review Policy, CMC Standards, GDP/Supply Chain, GMP Policy, General, International, International Harmonization, Other ICH, PIC/S, Region/International, Shipping & Storage, Supply Chain/GDPs, The News in Depth, WHO | Read More »

Congressional Bills Address FDA Supply Chain Oversight

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September 27, 2011 | Posted in Anticounterfeiting, Component Supply, Diversion, GDP/Supply Chain, GMP Enforcement Activity, GMP Policy, General, News Brief, Recalls, Region/International, Shipping & Storage, Supply Chain/GDPs, Track and Trace, US/Canada | Read More »

FDA Warning Letter to Chinese API Firm Cites Cross-Contamination Concerns

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September 27, 2011 | Posted in Asia, GMP Deviations/Warning Letters, GMP Enforcement Activity, Injectable, News Brief, Oral | Read More »

BLA CMC Problem Areas Include Lack of Transparency in Supplement Cover Letters, FDA Reports

FDA is urging sponsors filing Biologic License Application (BLA) supplements to clearly highlight the significant changes and their scope in the cover letter to expedite the agency review and approval process....
September 22, 2011 | Posted in Biotech Therapeutics, CMC Review Policy, Injectable, Marketing Application/General, The News in Depth, US/Canada, Vaccines/Biologicals | Read More »

FDA Renews Request to Congress for Additional Supply Chain Authorities

At a US Senate hearing on September 14, FDA renewed its request for new tools to more effectively and efficiently oversee the global supply chain and better protect the public from substandard, adulterated and counterfeit drug products....
September 19, 2011 | Posted in Agency Management, GDP/Supply Chain, GMP Enforcement Activity, GMP Policy, General, Inspection Initiatives, International, Region/International, Supply Chain/GDPs, The News in Depth, US/Canada | Read More »

EMA Releases Q&A on Marketing Authorization Transfers

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September 17, 2011 | Posted in CMC Review Policy, Europe, Marketing Application/General, News Brief, Region/International | Read More »

Early Attention to Analytical Method Development Can Be Critical to Product Success Later, FDA Cautions

FDA is cautioning firms to pay close attention to analytical method development early in the product lifecycle to avoid the problems the agency is seeing during application review stemming from poorly validated methods....
September 14, 2011 | Posted in Biotech Therapeutics, CMC Review Policy, Marketing Application/General, Post-approval Changes, Region/International, Specific Product Type, The News in Depth, US/Canada, Uncategorized, Vaccines/Biologicals | Read More »

FDA’s Foreign Office Experience Supports Their Benefit to Global Supply Chain Regulation

FDA’s growing experience with the field offices it has established in India, China and eight other countries is substantiating their benefit in boosting the agency’s efficiency and effectiveness in regulating a global supply chain....
September 7, 2011 | Posted in API, Asia, CMC Review Policy, GMP Deviations/Warning Letters, GMP Enforcement Activity, General, Inspection Initiatives, Inspections/Info Sharing, International Harmonization, Marketing Application/General, Region/International, Supply Chain/GDPs, The News in Depth | Read More »
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