Archive for January 2020

Trinidad-based OTC drug manufacturer CGA drew a warning letter from the FDA for serious GMP lapses including inadequate testing and producing an unapproved drug. Source: Drug Industry Daily

Trials for hematologic malignancies can use measures of minimal residual disease (MRD) as a biomarker, according to a final guidance issued by the FDA that specifies the types and uses of measures the agency will accept. Source: Drug Industry Daily

Gilead fired back at HHS’s patent infringement suit over its HIV drugs Truvada and Descovy, claiming that the patents the department is suing over are invalid. Source: Drug Industry Daily

The Institute for Clinical and Economic Review (ICER) released a draft cost-benefit analysis comparing three sickle cell disease treatments — Novartis’ Adakveo, Global Blood Therapeutics’ Oxbryta and Emmaus Life Sciences’ Endari — predicting that the expected cost would exceed the benefit for all three products. Source: Drug Industry Daily

The European Medicines Agency issued a draft paper to clarify the responsibilities of marketing authorization holders (MAHs) under the EU’s GMP regulations, which the EMA conceded can be confusing. Source: Drug Industry Daily

CDER spelled out current good manufacturing practices for drug compounders that register as outsourcers in a new draft guidance — and noted when the FDA does not intend to take regulatory action. Source: Drug Industry Daily

The FDA released two final guidances yesterday outlining the agency’s approach to drug-drug interaction (DDI) studies for DDIs mediated by cytochrome P450 (CYP) enzymes and transporters. Source: Drug Industry Daily

In a final guidance, the FDA outlined the new structure of the user fee program under the Biosimilar User Fee Act of 2017 (BSUFA II) which eliminated certain fees and extended the agency’s authority to collect fees through fiscal 2022. Source: Drug Industry Daily