Just a few documents this week with three from FDA, two from EMA and one from TGA. The two EMA guidance address implementation of the new MDR regulations in 2020. We have the usual collection of non-guidance publications from EMA, FDA, MHRA, MHRA and TGA. Enforcement from FDA included one warning letter to a compounding pharmacy, recalls and import [...]
This week the FDA published five guidance documents, Canada and the HPRA each published one. We provide the usual collection of non-guidance from the EMA, FDA, MHRA, and others. For enforcement this week saw one warning letter issued to a clinical trial investigator and one to a pharma company. There was also a collection of forms 483 issued to [...]
The FDA published three guidance focused on generic drugs, two of which address requirements for transdermal patches. The EMA published revisions to a Q&A, and the HPRA published one guidance. We include the usual collection of non-guidance documents from the FDA, EMA, MHRA and one from HPRA. Enforcement included one warning letter to a device firm, a handful of [...]
Happy reading! Barbara FDA: DEVICE: The FR announced availability of a draft guidance ‘Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions’ DEVICES: The FR announced availability of a proposed rule, ‘Medical Device Submissions: Amending Premarket Regulations that Require Multiple Copies and Specify Paper Copies to be Allowed [...]
Three guidance documents from the FDA, none from the EMA and two from WHO and one from CDSCO. The usual collection of non-guidance publications from the FDA, EMA, MHRA and a couple from HPRA and one from CDSCO. In terms of enforcement one warning letter was issued to a PET drug manufacturer, one to a device firm and one [...]
Lots of activity this week for FDA in publishing guidance documents, both draft and final. This included guidance addressing compounding pharmacies, devices, and generic drugs. TGA also published one regarding mandatory reporting for drug shortages starting in 2019. We also see the usual collection of non-guidance publications from FDA, EMA and MHRA. Enforcement was a bit slow this week [...]