It was fairly easy to predict the FDA would invoke enforcement discretion for the wholesale distributor’s saleable returns requirement of the Drug Supply Chain Security Act (DSCSA), as they announced last Tuesday (see “Is The FDA About To Delay Enforcement Of The Wholesaler’s 2019 Mandate?”). The deadline for the mandate was originally this November 27, but with the announcement, will not be enforced until November 27, 2020.
Continue reading No Surprise: DSCSA Verification Delay
Last week, Dr. Ilisa Bernstein, Deputy Director, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, spoke last week at the Healthcare Distribution Alliance (HDA) Traceability Seminar (see “HDA Traceability Seminar: RxTrace Future Topic List Explodes“). Her presentation went beyond the simple, tight-lipped, high-level review of the Drug Supply Chain Security Act (DSCSA) that is typical of recent FDA presentations at conferences. It was a refreshing change.
I hope you were able to attend last Friday’s FDA DSCSA Public Meeting at FDA’s White Oak, Maryland campus (see “FDA To Hold DSCSA Public Meeting”). If you missed it, make sure you listen in on the recording that the FDA will provide on the event webpage. You can also submit written comments through that page as well. The event was called “Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act (DSCSA)” and it consisted of very brief introductory comments by the FDA followed by presentations made by attendees who applied for a speaking slot. Presentations covering progress toward the November 27, 2017 DSCSA serialization requirements were made by: Continue reading FDA Forfeits Opportunity To Guide Industry
Tuesday’s FDA stakeholder call with Dr. Ilisa Bernstein, deputy director in the FDA’s Center for Drug Evaluation and Research (CDER) Office of Compliance, was helpful if only to let us know that the FDA has begun to mobilize immediately after the Drug Quality and Security Act (DQSA) was signed into law by President Obama last week (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law” and “InBrief: Comments on H.R. 3204 by FDA’s Dr. Ilisa Bernstein at PSM Interchange 13”). The call was very thin on what their plan is, but that was the point. Dr. Bernstein wanted everyone to know Continue reading FDA: Ready, Set, Hike!
Dr. Ilisa Bernstein, Pharm.D, JD, Deputy Director of the U.S. FDA Office of Compliance in the Center for Drug Evaluation and Research (CDER), delivered the keynote address at yesterday’s Partnership for Safe Medicines (PSM) Interchange 2013 event (see “Dr Ilisa Bernstein of FDA CDER Office of Compliance To Keynote PSM Interchange”).
Her presentation covered the full range of activities that the FDA is currently pursuing to improve the security of the U.S. pharmaceutical supply chain, including their efforts to implement the new powers they were given by Congress in last year’s FDA Safety and Innovation Act (FDASIA). Continue reading InBrief: Comments on H.R. 3204 by FDA’s Dr. Ilisa Bernstein at PSM Interchange 13
The Partnership for Safe Medicines (PSM) announced recently that Ilisa Bernstein, Pharm.D, JD, Deputy Director of the U.S. FDA Office of Compliance in the Center for Drug Evaluation and Research (CDER), will be the keynote speaker at their annual Interchange event next Thursday, October 24, 2013 at the Newseum in Washington DC. RxTrace is a media partner for the event again this year and I plan to attend.
According to the PSM website:
“The annual Interchange brings together policymakers, pharmaceutical manufacturers, patient advocates, law enforcement, healthcare professionals, and anti-counterfeiting companies to discuss the problem and solutions to the global scourge of pharmaceutical counterfeiting.”
Dr. Bernstein Continue reading Dr Ilisa Bernstein of FDA CDER Office of Compliance To Keynote PSM Interchange
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