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February 06, 2015
The agency releases guidance documents on Individual Patient Expanded Access Applications and disclosing risk information to patients.
February 02, 2015
Biosimilars, supply chain security, quality metrics, and elemental impurities headline guidance topics on FDA’s 2015 agenda.
January 26, 2015
FDA guidance discusses factors to consider in evaluation of photosafety and describes nonclinical photosafety tests.
January 23, 2015
EMA Recommends Suspension of 700 Drugs Tested at GVK Site GVK Biosciences argues that EMA’s recommended suspension of 700 drugs is disproportional to reported infractions. The European Medicines Agency (EMA) has issued a recommendation that 700 medicines authorized for use in the European Union (EU) should be suspended, based on concerns about how GVK Biosciences, a contract research organization in Hyderabad, India, conducted clinical studies. GVK Biosciences, in response, argued “the action is unprecedented and highly disproportional.”
January 09, 2015
A guidance document published just before the Jan. 1, 2015 deadline adds a four-month grace period.
January 02, 2015
The Parenteral Drug Association report addresses prevention and communication of drug shortages caused by manufacturing and quality related disruptions.
December 31, 2014
Analytical and procedural deficiencies result in FDA warning letter for Novacyl Wuxi Pharmaceutical.
December 18, 2014
ICH elemental impurities guideline sets a global policy for limiting metal impurities in drug products and ingredients.
December 17, 2014
The agency publishes two guidance documents on providing regulatory submissions in electronic format.
December 05, 2014
The guidance seeks to help generic and biosimilar drug sponsors gain access to reference products from brand-name manufacturers.