Regulatory/GMP Compliance

Aug 29, 2018
By BioPharm International Editors
PDA Technical Report 80 (TR 80): Data Integrity in Laboratory Systems is the first in a series of three technical reports PDA will publish on data integrity.
Aug 28, 2018
By BioPharm International Editors
The European Commission (EC) has approved Novartis’ chimeric antigen receptor T cell (CAR-T) cell therapy Kymriah for the treatment of B-cell acute lymphoblastic leukemia and relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.
Aug 27, 2018
The Senate approved a $159-million budget increase for FDA, to bring its resources up to $5.4 billion for 2019, including more than $2 billion in user fees.
Aug 24, 2018
By BioPharm International Editors
FDA sent a warning letter to Kyowa Hakko Bio Co., Ltd. after inspectors found data integrity problems at the company’s Yamaguchi, Japan facility.
Aug 23, 2018
By BioPharm International Editors
As a contingency against border delays resulting from a “no-deal” Brexit, the Department of Health and Social Care (DHSC) directs pharma companies to stock extra medicines.
Aug 23, 2018
By BioPharm International Editors
Guidances for regulatory changes, batch testing, and reporting address situations resulting from “no-deal” Brexit scenario.
Aug 17, 2018
By BioPharm International Editors
FDA approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector.
Aug 16, 2018
By BioPharm International Editors
FDA sent a warning letter to Apotex Research Private Limited after investigators found current good manufacturing practice violations.
Aug 15, 2018
By BioPharm International Editors
FDA published a resource guide to promote responsible opioid prescribing in the treatment of animals.
Aug 13, 2018
By BioPharm International Editors
BioPharm International spoke with Sharon Ayd, founder & CEO of Ayd Biopharmaceutical Consulting Services, about what the future holds when it comes to ensuring quality in biopharmaceuticals.
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