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May 01, 2015
The revised "21st Century Cures” proposal includes provisions for research for continuous manufacturing, biomarker development, and NIH funding.
April 28, 2015
FDA releases long-awaited guidance documents regarding the assessment of biosimilarity.
April 21, 2015
The agency has released draft guidance on providing regulatory submissions in regards to promotional labeling and advertising materials.
April 16, 2015
At the request of FDA, US Marshals seize unapproved prescription drugs from Florida distributor.
April 15, 2015
The document serves as guidance for the pharmaceutical industry in data integrity issues and complements existing EU GMP relating to APIs and dosage forms.
April 14, 2015
The European Medicines Agency releases guidelines for addressing and reporting risks associated with medication errors.
April 10, 2015
FDA issues a Warning Letter to Hospira S.p.A. for GMP violations at the company’s Liscate, Italy facility.
April 02, 2015
Process design experimental data and risk assessments are used to predict expected process performance and establish process performance qualification acceptance criteria.
March 30, 2015
A consensus-based standard issued by NSF International incorporates regulatory and industry requirements into a single standard for the manufacturing and distribution of pharmaceutical excipients.
The agency outlines recommendations for the development and submission of near infrared analytical procedures.