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Stress Test For WHO’s Quality Certificate Scheme In The Americas

A project being run in the Americas will assess the way that the Certificate of a Pharmaceutical Product is used and whether it meets the needs of countries in the region. The move is part of the revision of the World Health Organization’s quality certification scheme.
Quality Regulation

New Filings At The EMA

New medicines under evaluation at the European Medicines Agency.
European Performance Tracker Drug Review

Non-Traditional Antimicrobials Can Follow Regulatory Path Laid By Small Molecule Antibiotics, US FDA Says

Live biotherapeutics, fecal microbiota transplants and bacteriophages may be novel when it comes to fighting hard-to-treat infections, but their development and route to approval may not be all that different than traditional antibiotics, officials from FDA’s drugs and biologics center say.


Drug Approval Standards Clinical Trials

Novartis Diabetes Triple Drug Combination Deemed 'Irrational' In India

Novartis’s plans for triple drug diabetes combination which includes vildagliptin have been turned down in India at least for now, with an expert panel questioning the rationale of such therapy.
Review Pathway Metabolic Disorders

Opioid Bills Could Enhance US FDA Approval, Withdrawal Authority

House opioid package includes ability to deny or withdraw products because of abuse potential, but new Senate package does not, setting up potential conference battle.

Review Pathway Neurology

Gene Therapy INDs In China: Five Things To Consider

China is overtaking the US as the largest cell development market, with over 2,300 registered clinical trials. 

China Regenerative Medicine

US FDA May Start Missing ANDA User Fee Goals – In Order To Speed Approvals

Agency will work past generic goal dates if approval can be achieved quickly thereafter, but now must create policy defining criteria for those situations.
Generic Drugs Review Pathway

Will GDUFA III Curtail Priority Assessments?

US FDA's expedited pathway for generics seems to provide more benefits for amendments than for original ANDAs.
Generic Drugs Review Pathway

‘Regulatory Reliance’ Projects Bearing Fruit In Caribbean & Africa

Initiatives to promote information sharing and reliance among developing country regulators are bearing fruit in the Caribbean and Africa, although much works remains to be done, according to speakers at last week’s pre-ICDRA conference in Dublin.

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