# adverse — RSS Amplifier Recent posts from the 3 feeds in the RSS Amplifier directory that cover adverse. Page: Feed: --- ## [Regulatory Harmonization and Convergence](http://www.fda.gov/vaccines-blood-biologics/international-activities/regulatory-harmonization-and-convergence) _2026-08-17 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ The Agency engages in a range of explicit harmonization initiatives, a subset of which includes the participation of CBER. ## [Exporting CBER-Regulated Products](http://www.fda.gov/vaccines-blood-biologics/compliance-actions-biologics/exporting-cber-regulated-products) _2026-08-17 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ The Division of Case Management (DCM) within CBER's Office of Compliance and Biologics Quality (OCBQ) directs and coordinates CBER's export programs, including review of requests for export of unapproved CBER-regulated products. ## [Tissue Establishment Registration](http://www.fda.gov/vaccines-blood-biologics/biologics-establishment-registration/tissue-establishment-registration) _2026-08-17 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ Establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulated solely under section 361 of the Public Health Service (PHS) Act are required to register with FDA pursuant to 21 CFR Part 1271. Also, provided information on when to register update regist ## [Blood Establishment Registration and Product Listing](http://www.fda.gov/vaccines-blood-biologics/biologics-establishment-registration/blood-establishment-registration-and-product-listing) _2026-08-17 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ All owners or operators of establishments that manufacture blood products are required to register with the FDA, pursuant to section 510 of the Federal Food, Drug, and Cosmetic Act, unless they are exempt under 21 CFR 607.65 ## [Collaborations and Partnerships](http://www.fda.gov/vaccines-blood-biologics/science-research-biologics/collaborations-and-partnerships) _2026-08-17 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ CBER Research Collaborations and Partnerships ## [Vaccine Adverse Event Reporting System (VAERS) Questions and Answers](http://www.fda.gov/vaccines-blood-biologics/vaccine-adverse-events/vaccine-adverse-event-reporting-system-vaers-questions-and-answers) _2026-08-17 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ VAERS is a national vaccine safety surveillance program created as an outgrowth of the National Childhood Vaccine Injury Act of 1986 (NCVIA) and is administered by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC). ## [Vaccine Adverse Events](http://www.fda.gov/vaccines-blood-biologics/report-problem-center-biologics-evaluation-research/vaccine-adverse-events) _2026-08-17 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ Information about the Vaccine Adverse Event Reporting System (VAERS), which is a national vaccine safety surveillance program co-sponsored by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) to detect possible signals of adverse events associated with v ## [CYFENDUS](http://www.fda.gov/vaccines-blood-biologics/vaccines/cyfendus) _2026-08-17 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ For use as a post-exposure prophylactic vaccine following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial regimen. ## [Drugs@FDA Data Files](http://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files) _2026-08-17 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD) ## [Human Cell & Tissue Products (HCT/P) Adverse Reaction Reporting](http://www.fda.gov/vaccines-blood-biologics/report-problem-center-biologics-evaluation-research/human-cell-tissue-products-hctp-adverse-reaction-reporting) _2026-08-14 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ Human Cell & Tissue Products (HCT/P) Adverse Reaction Reporting ## [Trade Bitcoin & Ethereum (Sponsored)](https://crawlproof.com/a/VVJWYImLwxR3) _2026-08-14 · **Sponsored**_ Buy, sell and margin trade BTC & ETH with fiat currencies ## [What’s New for Biologics](http://www.fda.gov/vaccines-blood-biologics/news-events-biologics/whats-new-biologics) _2026-08-14 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ Latest news from the Center for Biologics Evaluation and Research ## [BioThrax](http://www.fda.gov/vaccines-blood-biologics/vaccines/biothrax) _2026-08-13 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ BioThrax is indicated for the active immunization for the prevention of disease caused by Bacillus anthracis in persons 18 through 65 years of age. ## [Commissioner's National Priority Voucher (CNPV) Pilot Program](http://www.fda.gov/industry/commissioners-national-priority-voucher-cnpv-pilot-program) _2026-08-13 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ FDA Commissioner's National Priority Voucher Program. The Commissioner's National Priority Voucher Program offers an unprecedented opportunity to reduce drug and biologic review times from 10-12 months to just 1-2 months. ## [Phase 1 Investigational New Drug (IND) Navigator](http://www.fda.gov/industry/phase-1-investigational-new-drug-ind-navigator) _2026-08-13 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ The Phase 1 IND Navigator provides the tools, guidances, and regulatory expertise you need to prepare and submit an successful Investigational New Drug (IND) application. ## [FDA Actions to Accelerate and Modernize Early and Late-Stage Clinical Development](http://www.fda.gov/industry/fda-actions-accelerate-and-modernize-early-and-late-stage-clinical-development) _2026-08-13 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ Learn more about actions to accelerate and modernize clinical research across the full continuum of drug development —from the Investigational New Drug (IND) phase to late-stage pivotal trials. ## [CMC and GMP Guidances](http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/cmc-and-gmp-guidances) _2026-08-13 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ This page lists CMC and GMP Guidance documents. ## [Recently Issued Guidance Documents](http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/recently-issued-guidance-documents) _2026-08-13 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ This page lists Recently Issued CBER and Cross-Center Guidance Documents. ## [Labeling for CBER-Regulated Products](http://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/labeling-cber-regulated-products) _2026-08-13 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ Labeling for CBER-Regulated Products ## [Laboratory Information Bulletins](http://www.fda.gov/science-research/field-science-and-laboratories/laboratory-information-bulletins) _2026-08-13 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ Laboratory Information Bulletins available to the public ## [Administrative Guidances](http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/administrative-guidances) _2026-08-12 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ This page lists Administrative Guidance documents. ## [AI publishing with human taste (Sponsored)](https://crawlproof.com/a/0kyBWUZG0JIt) _2026-08-12 · **Sponsored**_ Convert AI research into blogs, podcasts, and newsletters with optional human review. ## [Adverse Selection & Markouts](https://machow.ski/posts/markouts_and_adverse_selection/) _2026-07-27 · machow.ski_ Being a market maker isn’t for the faint of heart. Every quote you place is at risk of being picked off if you aren’t careful. In this article, I cover the concept of adverse selection, as well as how markouts can be used to measure it. ## [Transcytosis – what is it, and does it matter?](https://drmalcolmkendrick.org/2026/06/02/transcytosis-what-is-it-and-does-it-matter/) _2026-06-02 · Dr. Malcolm Kendrick · Dr. Malcolm Kendrick_ In my book the Clot Thickens, and in other blogs and lectures, I have stated that LDL cannot get through the endothelium (lining of blood vessel walls) and into the artery wall behind. So, the idea of LDL leaking from the bloodstream and into the artery wall is nonsense. Recently, however, people have been bombarding \[ \] ## [We Love Our Heart](https://drmalcolmkendrick.org/2026/05/26/we-love-our-heart-2/) _2026-05-26 · Dr. Malcolm Kendrick · Dr. Malcolm Kendrick_ This weekend, Sat 30th Sun 31st. WE LOVE OUR HEART – This weekend sat 30th, Sun 31st May Some of you may know of Mark Felstead and his tireless work to promote new ways to protect your heart, and keep lovely clean arteries where the blood flows fast and smooth. This weekend there is \[ \] ## [NICE and Wegovy – so much that cannot be seen](https://drmalcolmkendrick.org/2026/05/22/nice-and-wegovy-so-much-that-cannot-be-seen/) _2026-05-22 · Dr. Malcolm Kendrick · Dr. Malcolm Kendrick_ \[Part two of a review on the National Institute for Health and Care Excellence (NICE). Which approved Wegovy (semaglutide) for use in preventing CV disease\]. Stripping it down to basics, the key messages from the NICE report were: You may have noticed three little black boxes. Yes, redacted, redacted, and … yes, well, redacted once \[ \] ## [WEGOVY THE WONDER DRUG](https://drmalcolmkendrick.org/2026/05/19/wegovy-the-wonder-drug/) _2026-05-19 · Dr. Malcolm Kendrick · Dr. Malcolm Kendrick_ Lose weight, reduce the risk of CV disease – unless you are taking Wegovy? \[A tale of mystery and intrigue unfolds\]. A lot of people have asked me about the weight loss drugs known as glucagon-like peptide-1 receptor agonists (GLP-1 agonists) e.g. Wegovy (semaglutide), or Mounjaro (tirzepatide). What do I think of them, are they \[ \] ## [Final bit (probably) on the CTT Oxford paper](https://drmalcolmkendrick.org/2026/05/01/final-bit-probably-on-the-ctt-oxford-paper/) _2026-05-01 · Dr. Malcolm Kendrick · Dr. Malcolm Kendrick_ When I started the process of critiquing the Lancet paper I thought I was going to strip it down to its component parts. However, I have come to realise this would take far too long. Even longer than it has already taken – which is probably too long. A truly detailed critique would mean that \[ \] ## [The war](https://drmalcolmkendrick.org/2026/04/01/the-war/) _2026-04-01 · Dr. Malcolm Kendrick · Dr. Malcolm Kendrick_ THE WAR When I first heard the CTT at Oxford had published their latest analysis on statin adverse effects I must admit I sighed deeply. Do they never give up? This was the latest salvo in a long running war between the pro-statinators and the anti-statinators. Or, as I like to think of it, those \[ \] ## [Lancet paper critique – Part 3](https://drmalcolmkendrick.org/2026/03/21/lancet-paper-critique-part-3/) _2026-03-21 · Dr. Malcolm Kendrick · Dr. Malcolm Kendrick_ Finally, you may think, some figures. In this blog I want to look at some of the figures on adverse effects seen in a number of statin trials such figures as it is possibly to unearth anyway. Unlike the CTT in Oxford I along with almost every other researcher in the world \[ \] ## [The latest Lancet paper on adverse effects – part two](https://drmalcolmkendrick.org/2026/02/28/the-latest-lancet-peper-on-adverse-effects-part-two/) _2026-02-28 · Dr. Malcolm Kendrick · Dr. Malcolm Kendrick_ Under-reporting or over-reporting? I am going to start part two by looking at the evidence for statins causing ‘non-imagined’ adverse effects. Or, to put it another way, real effects. My own view on this is that the adverse effects of statins are significantly under-reported. Mainly because patients often don’t associate the drug with the problem. \[ \] ## [The latest Lancet paper on statin adverse effects – Part One](https://drmalcolmkendrick.org/2026/02/18/the-latest-lancet-paper-on-statin-adverse-effects-part-one/) _2026-02-18 · Dr. Malcolm Kendrick · Dr. Malcolm Kendrick_ ‘A lie is halfway round the world, before the truth has a chance to get its boots on.’ A quote used most famously by Winston Churchill. A few of you may have noticed a recent paper in the Lancet written by the Oxford Cholesterol Treatment Triallists Collaboration (CTT). Much to no-one’s great surprise it fully \[ \] ## [Prime Noise-Cancelling Picks (Sponsored)](https://crawlproof.com/a/hEfU7WnhbfA4) _2026-02-18 · **Sponsored**_ Browse Prime-eligible, 4-star-and-up noise-cancelling earbuds with fast shipping and deals ## [Disruptive science (part two)](https://drmalcolmkendrick.org/2026/01/17/disruptive-science-part-two/) _2026-01-17 · Dr. Malcolm Kendrick · Dr. Malcolm Kendrick_ My son tends to dismiss the idea of watching any film from before about say, the year 1990. Terrible special effects, he informs me, and just too old. As for anything in black and white … no, just, no. Why watch old stuff, it’s rubbish. The fool. In science there also seems to be a \[ \] ## [Disruptive science – part one](https://drmalcolmkendrick.org/2025/11/07/disruptive-science-part-one/) _2025-11-07 · Dr. Malcolm Kendrick · Dr. Malcolm Kendrick_ I read an article in Nature magazine a couple of years ago which has nagged at me ever since. It highlighted the sobering fact there has been a collapse in disruptive science. ‘Disruptive’ science has declined — and no one knows why 04 January 2023 The proportion of publications that send a field in a \[ \] ## [My current thinking on Covid-19 – and other important issues](https://drmalcolmkendrick.org/2025/10/07/my-current-thinking-on-covid-19-and-other-important-issues/) _2025-10-07 · Dr. Malcolm Kendrick · Dr. Malcolm Kendrick_ \[Warning, this blog is long\] I have been silent for some time… I know, I know. I started looking at Covid-19 and ended up in some very strange places indeed. ‘Here be dragons.’ I ended up wandering about, making absolutely no progress. Eventually, I ground to a halt. My insurmountable barrier was highlighted in an \[ \] ## [The Cover up – Part One (context)](https://drmalcolmkendrick.org/2025/04/17/29896/) _2025-04-17 · Dr. Malcolm Kendrick · Dr. Malcolm Kendrick_ The Cover-up Part One (context) A cover up. Yes, I know, I have repeatedly said that I do not believe there was a great world-wide conspiracy around COVID. Instead, I think that almost everything that went on can be explained by incompetence, greed and panic. Which was then stoked up by various people, for \[ \] ## [Why do so many believe Covid was a plandemic?](https://drmalcolmkendrick.org/2025/03/22/why-do-so-many-believe-covid-was-a-plandemic/) _2025-03-22 · Dr. Malcolm Kendrick · Dr. Malcolm Kendrick_ This is primarily a matter of trust – and the lack of it. If it looks like a conspiracy, and quacks like a conspiracy … or, to change focus slightly to Covid. If it looks like 1984, and quacks like 1984 – it’s probably 1984. What happened with Covid I found extraordinary and scary. Within \[ \] ## [Does Sars-Cov-2 exist?](https://drmalcolmkendrick.org/2025/03/06/does-sars-cov-2-exist/) _2025-03-06 · Dr. Malcolm Kendrick · Dr. Malcolm Kendrick_ Does Sars-Cov-2 exist? I ask this question because a number of people have claimed the entire Covid pandemic was a made-up event. A ‘plandemic’ If you like. There was no new virus, it never existed. Others question whether or not viruses actually exist, as ‘they have never been seen.’ I get these comments quite a \[ \] ## [THE KENDRICK COVID ENQUIRY (As I humbly call it)](https://drmalcolmkendrick.org/2025/02/18/the-kendrick-covid-enquiry-as-i-humbly-call-it/) _2025-02-18 · Dr. Malcolm Kendrick · Dr. Malcolm Kendrick_ Part One (a): Are the facts, facts? ‘The great enemy of the truth is very often not the lie, deliberate and contrived and dishonest, but the myth, persistent, persuasive and unrealistic.’ John F. Kennedy. I do not think that anyone can write about Covid without first recognising that the facts, may not actually be ‘the \[ \] ## [What went on during Covid?](https://drmalcolmkendrick.org/2025/01/29/what-went-on-during-covid/) _2025-01-29 · Dr. Malcolm Kendrick · Dr. Malcolm Kendrick_ Brevity? \[Not my strong point\] Today, it is almost as if it never happened. The time of COVID-19 (which I shall simply call Covid from here on). It came, it went, it is now ancient history. Hardly anyone wants to talk about it anymore. Why not? I suppose you could say, what’s the point? You \[ \] ## [Finally – the end (of the trial process)](https://drmalcolmkendrick.org/2024/12/05/finally-the-end-of-the-trial-process/) _2024-12-05 · Dr. Malcolm Kendrick · Dr. Malcolm Kendrick_ And so, we reach the final end to the court case. You may think it all finished months ago, not so. The final, final act is when we have the reading of the Statement in Open Court (SIOC). This took place Thursday the 5th of December 2024. Which is five years and nine months after \[ \] ## [A little more on the trial](https://drmalcolmkendrick.org/2024/11/07/a-little-more-on-the-trial-2/) _2024-11-07 · Dr. Malcolm Kendrick · Dr. Malcolm Kendrick_ When the background information leading up to the libel trial was released to us, there was one trail of e-mails that struck me as very damning. It emerged that Barney Calman was very keen to find case histories where people had stopped taking statins and then suffered a catastrophic event, such as a heart attack \[ \] ## [The legal case – naming a few names](https://drmalcolmkendrick.org/2024/10/30/the-legal-case-naming-a-few-names/) _2024-10-30 · Dr. Malcolm Kendrick · Dr. Malcolm Kendrick_ When the Mail on Sunday published their libelous articles about me on March 3rd, 2019, I was expecting it. I wasn’t expecting them to arrive on that precise date, or in that specific newspaper. But I had been waiting for something very unpleasant to appear, somewhere. Although I have to say that the level of \[ \]