Standards & Regulation

Aug 19, 2016
The legal battle between the Broad institute and UC Berkeley heated up after an email was released from a former graduate student.
Aug 18, 2016
By Pharmaceutical Technology Editors
Arbor Pharmaceuticals is voluntarily recalling Cetylev (acetylcysteine) effervescent tablets due to inadequate seal of the blister pack.
Aug 17, 2016
Nine public health organizations submitted a letter to US House and Senate committees citing concerns about Section 11 of the FDA and NIH Workforce Authorities Modernization Act.
Aug 17, 2016
By Pharmaceutical Technology Editors
The Chinese facility was cited for data integrity violations.
Aug 16, 2016
By Pharmaceutical Technology Editors
The company received breakthrough therapy designation for esketamine, a treatment for major depressive disorder with imminent risk for suicide.
Aug 16, 2016
By Pharmaceutical Technology Editors
The agency publishes guidance on the appropriate classification of co-crystal solid-state forms.
Aug 11, 2016
By Pharmaceutical Technology Editors
The agency released the GMP guidance to help manufacturers ensure accurate data and minimize risk.
Aug 10, 2016
By Pharmaceutical Technology Editors
FDA issued a warning letter to contract testing laboratory, Adamson Analytical Laboratories, for CGMP violations.
Aug 09, 2016
By Pharmaceutical Technology Editors
The three-year report emphasizes the roll of collaboration in drug safety.
Aug 09, 2016
By Pharmaceutical Technology Editors
The company is voluntarily recalling liquid products due to possible Burkholderia cepacia contamination.
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