Director, Office of Pharmaceutical Quality at FDA’s CDER. The views and information presented are mine. Retweets don't imply support, endorsement, etc.
Joined February 2020
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Come join us!! This symposium, held every two years, will explore topics related to pharmaceutical quality regulation, supply chains, and advanced manufacturing technologies. lnkd.in/efh8idBt
FDA’s Center for Drug Evaluation and Research (CDER) is establishing a program to promote quality management maturity (QMM) at drug manufacturing establishments. Read more about it.
fda.gov/media/171705/downloa…
1 day, 2 key documents to evolve the regulatory framework for advanced manufacturing: final internationally harmonized guidance (ICH Q13) on continuous manufacturing and a public discussion paper on the use of AI in drug manufactur…lnkd.in/eSyw3v3a lnkd.in/edF-JFPP
The Office of Pharmaceutical Quality (OPQ) in FDA’s Center for Drug Evaluation and Research is proud to publish its 2022 Annual Report. OPQ uses four strategic priorities to assure that quality drugs are available to the American p…lnkd.in/em5XYHYq lnkd.in/ej4uYkmD
GDUFA-funded research expands CDER’s understanding of drug products and especially the quality and performance of complex products. The comprehensive and just-released FY22 GDUFA Science and Research Report explains more: lnkd.in/eiKXx8PN
When I joined FDA: 1 approved biosimilar product. Now: 40. There is still progress to be made but advancements in science made this possible. OPQ’s Dr. Steve Kozlowski talks about new projects funded by the Biosimilar Regulatory Science Program: lnkd.in/eSBZav_q
FDA recently held two pilot programs to assess the quality management maturity (QMM) of drug manufacturers. See the lessons learned.
lnkd.in/geiwGPvJ
We are eager to engage with stakeholders on the development of a quality management maturity program and will be hosting a two-day workshop this month on May 24 and 25 for stakeholders to discuss their thoughts, perspectives and fe…lnkd.in/gT3Nahc2 lnkd.in/g7crUxWA
See how OPQ supported drug approvals, inspected facilities, maintained CDER’s surveillance catalog (>275K products!), provided guidance to industry, and kept substandard products off the shelf in 2021 lnkd.in/ea4cjCDG
A busy month! Wrote an article with @FDACDERDirector and FDA just released guidance on continuous mfg:
go.usa.gov/xMH5F
go.usa.gov/xMH5u
Join me at the Pharma Quality Symposium 10/26-27 to hear more about innovations: sbiaevents.com/pqs2021/
In case you want to hear about the latest updates from FDA’s Center for Drug Evaluation Research (CDER) regarding policy and approaches toward manufacturing, supply chain, and inspections during the COVID19 Public Health Emergency…lnkd.in/dYRE3TTc lnkd.in/dYWtUM7A
Please join us for this SBIA Webinar! lnkd.in/dTtYgR99
FDA In Brief: FDA Finalizes Guidance with Internationally Harmonized Recommendations to Further Support Safe, High-Quality Human Drug Products lnkd.in/enc7PQv
Michael Kopcha retweeted
Today, we issued a final guidance to provide a globally agreed upon framework to better manage certain post approval changes across a product’s lifecycle: go.usa.gov/xHAEf
Michael Kopcha retweeted
Today, FDA announced the availability of a guidance document entitled, “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the #COVID19 Public Health Emergency.” fda.gov/news-events/press-an…
Michael Kopcha retweeted
WATCH LIVE: Day 1 of the #CDERSBIA Drug Master File (DMF) and Drug Substance Workshop meeting has started.
The meeting will discuss the DMF review process, administrative aspects of managing a DMF, electronic submissions, and more!
youtu.be/UCpWaWzKpBk
Michael Kopcha retweeted
Our interview with OPQ chief @QualityKop: Newly Aligned Teams Sped US FDA’s Drug Quality Reviews Over Pandemic Hurdles pink.pharmaintelligence.info…
Proud of my OPQ staff’s accomplishments in 2020!!
FDA’s Office of Pharmaceutical Quality (OPQ) issued their 2020 Annual Report. The report covers their challenges & accomplishments in 2020 as they worked to assure the nation had access to safe, effective, quality medicines during the #COVID19 pandemic. go.usa.gov/xsCuR
FDA/CDER has an interim process to communicate issues to facility reps identified in info requested in lieu of inspection [704(a)(4) FD&C Act] & intends to consider their responses prior to taking action, as feasible. See revised guidance: lnkd.in/dJMeQed