Standards & Regulation

Mar 27, 2015
The White House confirmed that it would commit $1.2 billion to tackle the growing problem of antibiotic-resistant superbugs.
Mar 26, 2015
FDA has approved another indication for Eylea, a treatment for diabetic retinopathy in patients with diabetic macular edema.
Mar 25, 2015
By Pharmaceutical Technology Editors
Emergent BioSolutions announced FDA approval of Anthrasil, an inhalable treatment that targets Anthrax toxins, as well as a contract with BARDA to develop NuThrax, an anthrax vaccine candidate.
Pharmaceutical Technology: Mar 25, 2015
By Pharmaceutical Technology Editors
The commission adopts 24 new and 72 revised texts for inclusion in the European Pharmacopoeia.
Pharmaceutical Technology: Mar 24, 2015
By Pharmaceutical Technology Editors
The agency provides guidance on determining the need for environmental assessments for gene therapies, vectored vaccines, and viral and microbial products.
Pharmaceutical Technology: Mar 23, 2015
By Pharmaceutical Technology Editors
Guidance provides labeling standards and an implementation guide for electronic submission of lot distribution reports.
Pharmaceutical Technology: Mar 13, 2015
BIO and the Colorado BioScience Association urge Colorado Governor Hickenlooper to sign a bill that will help patients gain access to interchangeable biologic products following FDA approvals.
Mar 09, 2015
By Pharmaceutical Technology Editors
Astellas Pharma announced that it received FDA approval for its treatment of fatal invasive fungal infections in patients with blood cancers.
Mar 06, 2015
In a landmark decision, FDA approved Zarxio, making it the first biosimilar product in the United States.
Pharmaceutical Technology: Mar 02, 2015
A General Chapter on mAbs will be published in USP-NF as biologics increase their role in healthcare.