This has been an unusually slow summer week. Five documents published by FDA, three of which address user fees for FY2019 for Generic drugs, devices and food re-inspections, one from EMA and two each from WHO and TGA. Non-guidance publications were issued by FDA, EMA, MHRA ICH and HPRA. Enforcement was very slow with one warning letter issued to [...]
Among guidance documents this week are five from FDA, four from EMA and one each from Health Canada, HPRA and IMDRF. Two from EMA/EC address gene therapy. Non-guidance documents include the usual collection from MHRA, FDA, and EMA. Included here are expansion and renewal of the EU and Japan Mutual Recognition Agreement and a Biosimilar action plan from FDA. [...]
This week we include a brief supplement addressing warning letter enforcement actions taken in the first half of 2018. We will update this information, as we’ve done in the past few years, in a larger report at the end of the FDA fiscal year. On the guidance front, FDA published six draft guidance addressing a variety of gene therapy [...]
Warning Letters for the First Half of 2018 This article summarizes warning letter enforcement actions in the first half of the fiscal year 2018, October 1, 2017, through March 31, 2018. We look at the same attributes that we include in our annual analysis of the full fiscal years, and if some of the apparent changes hold up, they will [...]
Let’s start with a correction for an item from last week. The 32-page form 483 issued to Mylan that we covered was for a site in Morgantown West VA, not Pennsylvania. My geography isn’t the greatest! Apologies. Just a few guidance documents, and updates on non-guidance documents. Enforcement included three warning letters. For anyone interested in what FDA expects [...]
Happy reading! Barbara FDA: ADMINISTRATIVE BIOSIMILAR: The FR announced availability of a draft guidance ‘Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.” ADMINISTRATIVE: The FR published ‘Modifications to the list of Recognized Standards, Recognition List Number: ’ ADMINISTRATIVE: The FR announced availability of a draft guidance ‘Patient-Focused Drug Development: Collecting Comprehensive and Representative Input.’ [...]
Guidance documents this week were from the FDA, EMA and HPRA. Among the FDA ones are two programs where FDA will further pursue and investigate criteria for their Quality metrics program. The non-guidance documents include publications from MHRA, EMA, FDA, TGAA and ICH. Several are worth a serious read. By and large an unusually sparse week for enforcement. Warning [...]