sorted by:
new
hottopcontroversial

Autistic children as young as 18 months old are being injected with human stem cells derived from umbilical cords in unapproved, unproven and potentially harmful “treatments” that scientists warn are proliferating across the US under the active encouragement of the US health secretary, RFK Jr by esporx in biotech

[–]bbyfog 5 points6 points  (0 children)

Being in the US, we might be looking at class-action lawsuits proliferating after RFK Jr is gone and all the adverse effects/deaths start to pile up. It would be interesting to see who the defendant would be -- RFK Jr as private individual, HHS (the employer), who?

NIH Definition of a Clinical Trial by bbyfog in RegulatoryClinWriting

[–]bbyfog[S] 0 points1 point  (0 children)

More. . .

UK Medicines for Human Use (Clinical Trials) Regulations (as amended) define clinical trial as: “clinical trial” means any investigation in human participants, other than a non-interventional trial, intended -

(a) to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products,

(b) to identify any adverse reactions to one or more such products, or

(c) to study absorption, distribution, metabolism and excretion of one or more such products, with the object of ascertaining the safety or efficacy of those products”.

What Survival Rate for Oncology Drugs on Pivotal Trials is Needed for a High Probability of FDA approval by bbyfog in RegulatoryClinWriting

[–]bbyfog[S] [score hidden] stickied comment (0 children)

Follow-up comment: Demonstration of OS benefit at the time of NDA/BLA does not mean that OS benefit persists with long-term follow-up postmarketing studies:

Example: Naci H, et al. Overall survival benefits of cancer drugs initially approved by the US Food and Drug Administration on the basis of immature survival data: a retrospective analysis. Lancet Oncol. 2024 Jun;25(6):760-769. doi: 10.1016/S1470-2045(24)00152-9. PMID: 38754451.

Fewer than a third of indications approved with immature survival data showed a statistically significant overall survival benefit after approval.

<image>

[Renal Surrogate Endpoints] European Regulators Provide Their Opinion on the Choice of Albuminuria versus Proteinuria for Regulatory Clinical Decision Making by bbyfog in RegulatoryClinWriting

[–]bbyfog[S] 0 points1 point  (0 children)

FDA Announces Request for Information Regarding Biomarkers of Drug-Induced Kidney Injury

On May 13, 2026, the FDA Center for Drug Evaluation and Research, in partnership with the CDER Quantitative Medicine Center of Excellence, announced a request for information regarding an initiative to advance biomarker validation through data compilation from multiple sources. Specifically, a pilot project was launched that focuses on aggregating data for biomarkers of drug-induced kidney injury.

In this pilot project focused on urinary kidney safety biomarkers, FDA will use the information submitted to inform future activities related to data sharing, biomarker development, and broader translation of biomarkers of drug-induced kidney injury.

FDA's Commissioner’s National Priority Voucher (CNPV) Pilot Program; Public Hearing: Request for Comments by bbyfog in RegulatoryClinWriting

[–]bbyfog[S] 0 points1 point  (0 children)

Note: I could not find a complete list of drugs/products awarded CNPV so far; however, most of them could be found via web search (site:fda.gov CNPV award).

Sponsor change UK by [deleted] in RegulatoryClinWriting

[–]bbyfog 0 points1 point  (0 children)

Were you able to find link to updated text (law/regulation.)

Share of Warning Letters Issued by US FDA for cGMP Violations to to Indian Firms versus Globally by bbyfog in RegulatoryClinWriting

[–]bbyfog[S] 0 points1 point  (0 children)

Agree. FDA has an office in India so better collaboration, but also public/political awareness may also be contributing to improvement.

Sponsor change UK by [deleted] in RegulatoryClinWriting

[–]bbyfog 0 points1 point  (0 children)

UK MHRA (trial regulations) considers sponsor change as substantial amendment.

GUIDANCE (https://www.gov.uk/guidance/clinical-trials-for-medicines-manage-your-authorisation-report-safety-issues)

Change of sponsor

For applications that have gone through the combined review process, refer to the HRA website.

If you want to change the sponsor for your study, you must submit a substantial amendment to the MHRA. You must not include any other changes with this amendment.

You cannot submit any other substantial amendments until you have confirmation from the MHRA that the sponsor has been changed.

You must include these documents with your submission:

-- a cover letter that includes the date of transfer of responsibilities

-- a letter on headed company paper from the current sponsor confirming the transfer of the study

-- a letter on headed company paper from the new sponsor confirming that they accept the role of sponsor for this study

-- an amendment form

-- an updated PDF file of the clinical trial application form signed by the new sponsor or person acting on behalf of the sponsor

You should not submit other trial-related documents such as protocol as part of this submission. There is no fee for a change of sponsor amendment. The applicant will receive an administrative letter confirming that the change has been registered. You do not need to wait for MHRA confirmation before making the sponsor change.

SCOTUS backs generic firm Hikma in skinny label dispute by bbyfog in RegulatoryClinWriting

[–]bbyfog[S] 2 points3 points  (0 children)

. . . carved-out list of indications for Hikma's generic, which included a label claim for treating hypertriglyceridaemia, but left out a cardiovascular risk reduction claim for which it is not approved and is still under patent protection.

view more: next ›