Standards/Regulations

Sep 28, 2017
By Pharmaceutical Technology Editors
The draft guidance gives recommendations for reproductive toxicity testing and labeling.
Sep 27, 2017
By Pharmaceutical Technology Editors
The FDA commissioner made a statement about the agency’s efforts to ensure patient access to safe compounded medicines.
Sep 26, 2017
By Pharmaceutical Technology Editors
Staff survey on the relocation of EMA indicates that the future of public health in Europe is at stake.
Sep 25, 2017
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
FDA participated in a global operation to combat the sale and distribution of unapproved and illegal drugs.
Sep 25, 2017
Biopharmaceutical companies developing new competitive biotech therapies have pressed hard for clarity on the testing and data required by FDA to gain market approval of biosimilars that can be filled by a pharmacist without prescriber preapproval.
Sep 25, 2017
Pharmaceutical companies should prepare for the impact of recalls to minimize risk to consumers and the company.
Sep 21, 2017
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
The agency sent out 13 warning letters on Sept. 19, 2017 to companies selling drug products online.
Sep 19, 2017
By Pharmaceutical Technology Editors
Validation and batch testing failures were among the violations found by the FDA at the company’s Jiangsu facility.
Sep 15, 2017
By Pharmaceutical Technology Editors
European Medicines Agency’s Committee for Medicinal Products for Human Use grants a positive opinion for the approval of the biosimilar for treating breast cancer.
Sep 15, 2017
By Pharmaceutical Technology Editors
The approval marks the first biosimilar approved in the United States for treating cancers.
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