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Novel Clinical Trial Designs for Gene Therapies: An Exploration of Challenges by the National Academies’ Forum on Regenerative Medicine
…genome editing activity, prolonged expression of the transgene, potential for latency, and establishment of persistent infections. For more information on LTFU, we direct you to FDA’s Draft Guidance on LFTU…
Shhh! It’s a Secret! FDA is Not Providing Key Details in the EUA Templates
…section 1 above, low positive is defined by the comparator assay. If you pick a comparator that is more sensitive than your test, you will not only increase the likelihood…
Happy 40th Birthday Medical Device Amendments – You’re Officially Over-the-Hill
…with your complexity. You started off as an adorable little law. As we examined you more closely, we saw how multi-dimensional you were, bigger on the inside than the outside. …
What to Do When You Receive a DEA Order to Show Cause
…DEA’s decision. What Are Your Options When You Receive an Order to Show Cause? You have several options. The first is to request a hearing before one of DEA’s administrative…
Commissioner Gottlieb and CBER Director Marks Deliver “State of Cell and Gene Therapy” Joint Statement
…providing a state of union of sorts on the development and regulation of cell and gene therapy. This comes at a time when we are seeing exponential growth in the…
If You are A Mobile App Developer, Get it Right from the Start, Please!
…Get it Right from the Start.” They apply to you, whether you are a start-up app developer or an established business. The FTC wants you to tell the truth about…
Every Breath You Take . . . FDA is Watching You!
By Robert A. Dormer – Every breath you takeEvery move you makeEvery bond you breakEvery step you takeI’ll be watching you Every single dayEvery word you sayEvery game you playEvery night…
Fitting New Scientific Advances Into an Old Regulatory Paradigm (Part 2): Gene Therapy and Orphan Drug “Sameness”
…component in a gene therapy product. If FDA determines that both the genetic and vector components are relevant to a “sameness” determination because they both comprise the gene therapy product,…
When FDA Makes You An Offer You Can’t Refuse
…of a drug’s marketing application, the applicant submits a proposed PI that includes information about the drug’s “indications, effects, dosages, routes, methods, and frequency and duration of administration and any…
“You Can’t Handle the Truth!” Code Orange: Court Dismisses Lanham Act-Orange Book Therapeutic Equivalence Rating Complaint on Primary Jurisdiction Grounds
…concerning the nature, characteristics and qualities of the Generic Oxymorphone ER Tablets in connection with its commercial advertising and promotion of such Tablets constitutes a violation of Section 43(a) of…
FDA Grants Marketing Authorization to BioFire’s Multiplexed COVID Test – Lines Have Been Drawn
…that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 and…
Now You See It, Now You Don’t: Vanishing Drug Approval Information and Other FDA Actions Making Drug Approvals Opaque
…After all, when (and if) FDA posts a tentative or final ANDA approval letter, the date of application submission is provided and companies can use that information to make some…
You Better Watch Out, and You Can Pout, but FDA User Fee Invoices Are Coming Out; FDA is Making a List and Checking it Twice – You Should Too!
…the prescription drug establishment listed in the application does not engage in the manufacture of the prescription drug product during the fiscal year.” Companies who do not intend to engage…
A Historic Day in Drug Development: AveXis Gene Therapy for SMA Approved
…expert, deserve acknowledgment for their efforts on both this condition, SMA, and on gene therapies, generally. As for SMA, OTAT has paid special attention to the Voice of the SMA…
Eisai Says FDA Erroneously Triggered NCE Exclusivity Start Dates Before DEA Controlled Substance Scheduling Permitted Marketing
…a final scheduling decision.” DEA did not made a decision on the scheduling of lorcaserin until May 8, 2013, when it published a final rule, effective on June 7, 2013,…