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August 27, 2018
FDA proposed in a Federal Register notice that bumetanide, nicardipine hydrochloride, and vasopressin should not be included on the list of bulk drug substances that outsourcing facilities may use in compounding.
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.
August 24, 2018
Dompé Farmaceutici’s Oxervate (cenegermin), a topical eye drop, is the first treatment approved by the agency for neurotrophic keratitis, a rare disease affecting the cornea.
FDA sent a warning letter to Kyowa Hakko Bio Co., Ltd. after inspectors found data integrity problems at the company’s Yamaguchi, Japan facility.
August 23, 2018
Guidances for regulatory changes, batch testing, and reporting address situations resulting from “no-deal” Brexit scenario.
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.
August 17, 2018
FDA approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector.
August 16, 2018
FDA sent a warning letter to Apotex Research Private Limited after investigators found current good manufacturing practice violations.
August 15, 2018
FDA published a resource guide to promote responsible opioid prescribing in the treatment of animals.
August 13, 2018
The new drug, Onpattro (patisiran), by Alnylam Pharmaceuticals, is in a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.