Organicell Regenerative Medicine Inc. (BPSR.OB) has received FDA clearance to initiate a phase I/II multi-center clinical trial of Organicell Flow in patients diagnosed with moderate to severe acute respiratory syndrome (SARS) due to COVID-19 infection.

The federal government in March released a pair of long-awaited rules that will give patients greater access to their health data and improve the flow of information across care settings.

High rates of opioid prescribing have contributed to the current U.S. opioid epidemic and the steady increase in overdose deaths across the country. Prescribers wrote an all-time high of 255 million opioid prescriptions in 2012, and though that rate has since declined.

Care coordination is considered a hallmark of patient-centered treatment and has been shown to improve health outcomes and patient satisfaction as well as reduce costs. Defined as organizing patient care activities and sharing information among all participants concerned with an individual’s treatment plan in order to achieve safer and more effective results, care coordination is increasingly...

The spread of COVID-19 is placing unprecedented strain on Philadelphia’s hospitals, public health systems, and residents. Although the full effects of the emergency have yet to be realized, newly released data from 2018 and 2019 provides insight on the state of public health in the city before the pandemic.

The Pew Charitable Trusts sent a letter May 4 to the leaders of the Senate and House of Representatives urging them to support improved patient matching in electronic health records to help combat the COVID-19 pandemic.

Neuroscience has had a tough run of news lately. With Amgen deprioritizing neuro this year, Pfizer doing the same last year, and others like BMS, GSK, and AZ cutting back on CNS a few years earlier, it would seem dark

The post The Promise Of Precision Neuroscience And Launch Of Arkuda Therapeutics appeared first on LifeSciVC.

This blog was written by Ankit Mahadevia, CEO of Spero Therapeutics, as part of the From The Trenches feature of LifeSciVC.  If CEOs have empowered their teams effectively, they have three roles during times of rapid change: Motivator in chief

The post The Balancing Act: Taking A Systematic Approach To Hard Decisions In Times Of Rapid Change appeared first on LifeSciVC.

Baby Boomers, Gen X and Millennials are key consumer target groups for marketers, with three different sets of needs and buying propensities; it’s important that brands define their unique selling propositions.

The American Herbal Products Association submitted nearly 100 pages of comments to the Food and Drug Administration Center for Food Safety and Applied Nutrition identifying ways to improve regulations, guidance documents and enforcement practices to better protect public health.

Probi's largest clinical trial ever, focused on probiotic immune health, has recently been completed.

At Engredea 2018 in March in Anaheim, CA, OmniActive will be highlighting the latest addition to its ginger ingredient range, Gingever 10% powder, expanding its application to tablets, capsules and beverages.

Selling directly to health care practitioners, supplement companies can foster open dialogue about their products; but, every regulation applies to products in this channel, too.

A study demonstrated Wellmune® may protect intestinal barrier function in adults when faced with stress.

Another leading athlete has joined Arla Foods Ingredients’ growing number of brand ambassadors for Lacprodan® HYDRO.365.

Valensa International announced Non-GMO Project has been awarded to Valensa’s Organic Spirulina, Chlorella and Microalgae products.

Emport LLC is pleased to introduce new training programs and materials to augment its food safety and allergen control portfolio.

Applied Food Sciences, Inc. (AFS) takes the next step in demonstrating complete transparency by getting four of its core ingredients Non-GMO Project Verified.

ChromaDex Corp. announced NIAGEN® nicotinamide riboside prevented neurological damage and improved cognitive and physical function in a new mouse model of Alzheimer’s disease.

The chief executive of a supplement company under investigation by FDA could go to prison for allegedly violating the terms of his supervised release following a criminal conviction in 2014.

The best sports nutrition formulas designed to improve performance draw from a pool of ingredients researched for benefits to energy production, cognitive function and endurance both in general and specifically concerning muscles.

It is "inconceivable" that immunity will not remain high on the list of health priorities when this pandemic ends and now is the time to create more "convincing experiences" to ensure trial turns into adoption, according to food and drink research and branding experts.

Obese mice with unhealthy lifestyles gain significantly less weight and avoid type 2 diabetes when they receive bacteriophages from the faeces of a lean mouse, according to a new University of Copenhagen study.

APEC economies, data privacy regulators, and other stakeholders are exploring ways to bolster the Cross-Border Privacy Rules (CBPR) system.

Leaders from around the world gathered at the United Nations General Assembly in New York on 23 September for the first-ever United Nations High-Level Meeting (UNHLM) on Universal Health Coverage (UHC): Moving Together to Build a Healthier World.

Media Registration is Open for the APEC Informal Senior Officials’ Meeting

A duo of innovative programmers from Malaysia are the winners of the 2019 APEC Digital Prosperity Award, announced on the sidelines of the APEC Informal Senior Officials’ Meeting in Langkawi.

Media registration is open for the First APEC Senior Officials’ Meeting (SOM1) and related meetings in Putrajaya, Malaysia from 3 February to 22 February 2020.

Medical supplies and personal protective products are facing barriers worldwide

From : Communities>>Regulatory Open Forum
Hi everyone, I just finished it, and it is a really simple task! Go ahead! Thanks Anna --------------------------------- Anna Alonzi MD Sr. Regulatory Associate Newtown PA United States ---------------------------------

From : Communities>>Regulatory Open Forum
The short answer is "yes" provided that the development cell bank was the source for the GMP bank and is comparable in terms of performance. However, the devil is in details and you need to evaluate "comparability" carefully between the development bank and the GMP bank with respect to the characterization data you plan to use for, e.g., to support GMP bank for production, etc. Two ICH guidance documents are useful to look at, Q7 Table 1 and Q5D. The US FDA generally follows ICH guidance but EMA [More]

From : Communities>>Regulatory Open Forum
Yes, exactly i asked same

From : Communities>>Regulatory Open Forum
Thank you all for participating in our Tagging Project! We're glad to hear you enjoyed it. All volunteers were entered into a drawing for a $50 Amazon gift card. See a video of the drawing attached.  I'm happy to announce that the winner is ...  @Jonathan Amaya-Hodges ! Thanks again to all who participated. If you're interested in more volunteer opportunities, see our full list here .​​ ------------------------------ Danielle Fezell Manager, Chapter & Volunteer Relations, RAPS Rockville MD United [More]

Files Attached Document
RE: Sort It Out by participating in the RAPS Tagging Project

From : Communities>>Regulatory Open Forum
Thank you RAPS, what a pleasant surprise! I appreciate the opportunity to contribute to the project! Now, if only Amazon had any toilet paper in stock... ------------------------------ Jonathan Amaya-Hodges Associate Director, Regulatory Affairs CMC Combination Products and Medical Devices Cambridge MA United States ------------------------------

From : Communities>>Regulatory Open Forum
Hello,  I can see many unapproved combinations of Minoxidil as topical solution like minoxidil+ Azelaic Acid; Minoxidil + Finasteride; Minoxdil+ niacin+retinol+caffeine that are available online for sale in US but these drug products are not approved by FDA as visble from USFDA website.  Can anyone explain that is there any mechanism or guideline to allows to sell such unapproved drug products online in US and also in EU? Or is this totally illegal practice?  Thanks Ankur RAC

From : Communities>>Regulatory Open Forum
Hi, Ankur - Some may be "legal," others not. It's a big industry, and it is fair to be cynical. Combination products for sale that have not been approved-as the combination-by FDA are just that, unapproved drugs. I assume you checked for the approval status in FDA's "Orange Book" (https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm). Even if both active pharmaceutical ingredients in a 2-drug mixture were approved separately on their own, it does not mean the combined product is approved for [More]

From : Communities>>Regulatory Open Forum
These are all unapproved new drugs. Many people who have very limited knowledge of our OTC drug system, assume that if it is sold OTC, it is a monographed drug and they can change the formulation. They do not know that there are two types of OTC drugs allowed-compliance with a monograph or NDA. Minoxidil is one and chlorhexidine antiseptic wash is another. ------------------------------ David Steinberg,FRAPS President Steinberg & Associates, Inc. Pompton Plains NJ USA 609-902-8860 -------------- [More]

From : Communities>>Regulatory Open Forum
The only  possible way I can see any of these products being legally marketed in the US without going the OTC NDA route would be if the ingredients  other than Minoxidil are considered "inactive" and have some purpose (other than their active ingredient purposes) in the formulation.  That said, this might work for the last combination in your listing because all of these can and are often used in OTC products as inactive ingredients with understood and current reasons for existing in a formulation [More]

From : Communities>>Regulatory Open Forum
This message was posted by a user wishing to remain anonymous For device-lead drug combination products, is there any difference in the quality (grade) of API used compared to a pure drug product? The cGMP guidance for combination products does not seem to specify, and since drug claims cannot be made on device-lead drug combination products, it was not clear what quality of drug is required. Thank you!

From : Communities>>Regulatory Open Forum
​I doubt FDA would have any willingness to change the requirements or expectations for a drug product based on whether it is in a strictly drug product versus in a combination product.  The fact also that there is not a published allowance for this is further evidence that FDA expects that the drug will meet the requirements as expected for drug products without providing any allowed changes or classes of changes.  Remember, FDA expects that drug products meet specific requirements.  Things like [More]

From : Communities>>Regulatory Open Forum
These types of products and combinations you mention are all unapproved drugs and unapproved combinations.  Unless the specific combination is approved or listed in an OTC monograph, it is a new drug and requires a NDA to market it.  Minoxidil is a Rx to OTC switch product so it requires a NDA or ANDA to market this drug in the US, even as a OTC drug.  Thus any combination with minoxidil is a new drug. In the past the FDA has also specifically stated that combining different types of products (drug [More]

What if your favorite movie quotes were written for QA professionals? Would they be as memorable? We think so, but we’ll let you decide.

In the fall of 2015, the internet was rife with tweets sporting the hashtag #ScienceMovieQuotes.  Creative scientists repurposed their favorite movie quotes, gleefully infusing them with nerdy humor for the entertainment of their colleagues.  Such a great idea was just asking to be stolen.  And who are we to resist the siren call of piracy?  So here’s our best attempt at making #QAmovieQuotes go viral.*

…And because the rhymes were just too good, we couldn’t resist…




If you’re feeling creative, here are the American Film Institute’s 100 greatest movie quotes of all time.  Please share your humor!  (Fair warning – we took all the good ones.)

By Laurie Meehan

________________________________________________
* Thanks to Robyn Barnes of MasterControl for this fun idea.

Photo credits

Brando: User:Aggiorna / CC BY-SA-3.0, changes made
Badge: User:Dandvsp / Wikipedia Commons / CC BY-SA-3.0
Nicholson: User:Nikita~commonswiki / CC BY-SA-2.5, changes made
Shawn: Sam Felder / CC BY-SA-2.5, changes made
Leigh: Trailer Screenshot, A Streetcar Names Desire,1951, Public domain
Freeman: User:FRZ / CC BY-SA-2.5, changes made
Aladdin Chocolates: Hans Lindqvist, 2009, Public domain
Flower: Walt Disney, Bambi, 1942, Public Domain
Doune Castle: Keith Salveson / CC BY-SA-2.0
Bogart: Trailer Screenshot, Casablanca,1942, Public domain
Newman: Warner Bros. Entertainment, Cool Hand Luke, 1967, Public Domain

Year in and year out, protocol deviations are the most common FDA Site Inspection finding. Why does this keep happening?

If you’ve seen FDA’s Inspectional Observation Summaries, you know that in 2015 the most frequently cited violation in clinical research by far was “failure to conduct research in accordance with the investigational plan.”  Do you know this finding also topped the list the year before that?  And the year before that?  In fact, deviating from the protocol has been the most common observation every year for the last decade.

Why does this keep happening?



The Nature of Protocols
This will come as a surprise to no one: not all protocols are well written.  Important procedures can be hidden in the most obscure places.  Charts depicting Time and Events Schedules are famous for carrying dozens of footnotes that appear nowhere else in the protocol, yet convey important study procedures.   For instance, a pre-dosing column may include a footnote that provides a timeframe for performing a physical exam; a post-dosing footnote might specify the interval at which vitals must be taken.   Failing to follow study procedures compromises subject safety and data integrity; FDA won’t care whether the procedures were in big bold italics or 7-point font.

This, too, may come as no surprise, but not all protocols are error-free.   Information in charts may not match the narrative.  Procedures in Section A may conflict with procedures in Section B.  When the FDA investigator spots an inconsistency, you’ll be asked which of the two conflicting procedures you followed and why.  If you performed procedure A only because you didn’t even notice there was a B, it will be clear you didn’t read the protocol as thoroughly as you needed to.  The FDA investigator may become concerned that your study execution differed from the sponsor’s intention.  This is not a concern you want to trigger.

For these reasons, it’s imperative that study staff read and understand the protocol.  Study team members need to ask questions about anything they’re unsure of, seek clarification on protocol inconsistencies, and get responses that satisfy before starting the study.   A PowerPoint overview is not sufficient training.

One more irksome attribute of protocols that can make them difficult to follow -- they change.  While most study sites allocate time and resources for initial protocol training, many lack a plan for training staff on protocol amendments.   A disproportionate number of protocol deviations occur in amended procedures, and it’s often because staff members have been insufficiently trained on them.  (And when you do train on protocol amendments, don’t forget to document it.)

Deviation Temptation
A protocol is not a suggestion; PIs cannot substitute their own judgment for prescribed procedures, no matter how well-intentioned the departure.  The protocol for a psoriasis study might call for the PI to perform a series of punch biopsies, very invasive procedures.  After the first biopsy, an empathetic PI might be tempted to skip a second if he observes the plaque is clearing up; the drug is working.  But this would be a protocol deviation.  The protocol for another study might preclude the use of a particular drug, even though the drug is routinely used throughout the practice to treat a symptom that a study participant is exhibiting.  But the study protocol trumps standard of care; prescribing the drug would be a protocol deviation.

A PI who feels she must deviate from the protocol for some reason must obtain prior approval, since failure to follow the protocol can jeopardize the reliability of the study data, if not subject rights and safety.



Deviations Happen
So you’ve thoroughly read the protocol, you’ve asked your questions and received the necessary clarifications, you’ve trained your staff on the protocol and its amendments, and you do your best to follow them.

Despite all your preparation and vigilance, protocol deviations happen.  They just do.  And when they do, here are two don'ts.

(1) Don’t panic.

(2) Don’t let an FDA investigator find them first.
Take the time to fully document any protocol deviations.  Be sure to record why they happened, how they were corrected, and what was submitted to the IRB.

[Note: IRBs have different requirements about what types of protocol deviations should be communicated.  Out-of-window visits are common and are frequently considered too minor to report.  But nothing’s black and white.  If the missed visit resulted in missed doses, that would probably change the calculus. The PI needs to determine whether to notify the IRB, and if no submission is thought necessary, it’s a good idea to document why not.]

_______________________________________________________________

A version of this article originally appeared in InSite, the Journal of the Society for Clinical Research Sites.

Protocol trumps practice. This principle seems clear enough, but complying with it is not always as straight-forward as it sounds. Years of practicing medicine has reinforced the way a physician responds to medical situations. But do these responses run counter to the investigational plan? Can a site’s commitment to standard of care affect its ability to meet enrollment targets?


There’s a lot to consider.



What’s Your Standard of Care?
When deciding whether or not to conduct a particular study, a PI needs to verify that the protocol is aligned with practice norms. For example, an early phase trial might exclude a medication that is part of a practice’s routine therapy. Is the study placebo-controlled? Does it feature a specific comparator drug? Will it include a washout period? Any of these elements could present enrollment challenges or preclude a site from accepting a study at all. Responsible sites want to make thoughtful decisions about study suitability; they want to provide realistic enrollment estimates. Sponsors want this too, and can help sites do both these things by providing them a sufficient level of detail about protocol procedures as early as possible.


The Road to Deviations is Often Paved with Good Intentions
Therapeutic misconception – a well-documented phenomenon in clinical research – occurs when a study participant “fails to appreciate the distinction between the imperatives of clinical research and of ordinary treatment.”* Study participants are not alone in this. Researchers blur the distinction themselves when they conduct procedures that are consistent with clinical care but deviate from the protocol. This may be particularly true for PIs who recruit participants from their own practices. An endocrinologist might ordinarily reduce dosage for a particularly diminutive patient. A pulmonologist would often skip a scheduled chest x-ray she felt wasn’t needed to avoid exposing her patient to unnecessary radiation. An orthopedic surgeon may decide his patient needs more recovery time than usual before attempting her first walk. In a clinical care setting, these decisions are sound, made in an individual patient’s best interest. In a clinical trial, if they differ from the investigational plan and haven’t been approved by the Sponsor, they’re protocol deviations.**

It May be Par for the Course, But It's Still an AE
Specialists who have experience treating particular conditions are also familiar with the complications that ordinarily accompany them. A nephrologist, for instance, knows that a patient with end-stage renal disease frequently experiences bloat from a buildup of fluid between dialysis sessions. Though useful for a doctor treating patients, this knowledge can actually work against a doctor running a trial. How? A PI may fail to report a stomach ache as an AE because it’s so typical, so expected. “Bloat is common for renal patients. If I recorded every GI incident, I’d be recording AEs all day.” At its surface, this PI’s argument sounds reasonable, but what if the study drug itself is contributing to the participant’s discomfort? In order to assess the drug’s gastrointestinal effect, the PI must document the frequency and severity of all GI events.

Lab values that are either above or below normal range are also prime candidates for AE underreporting. “Of course the participant’s liver enzyme is high – we’re testing a cholesterol drug.”

The Importance of Study Oversight
Any GCP course worth its registration fee will discuss the distinction between standard of care and the study protocol. In practice, the distinction is not always as obvious as training sessions might suggest. This is where well-trained CRAs come in. As site monitors, CRAs are in a position to catch deviations that result from lapses into standard of care. Reading through progress notes, a monitor can ensure that any untoward medical event has been reported as an Adverse Event. They can verify that procedures conducted by the PI and site staff are compliant with the protocol. Then, by reviewing which types of data must be collected and emphasizing the importance of following certain protocol procedures, monitors can take the opportunity to re-educate study personnel and help them avoid these common pitfalls.

_______________________________________________________________________
* Lidz CW, Appelbaum PS (2002) The therapeutic misconception: problems and solutions. Med Care 40: V55-V63.

**Andrew Snyder of the HealthEast Care System wrote a thoughtful piece describing the compatibilities that do exist between clinical care and clinical research. His arguments provide a useful counterpoint to the issues we’re raising here. https://firstclinical.com/journal/2017/1707_Research_vs_Care.pdf

A version of this article originally appeared in InSite, the Journal of the Society for Clinical Research Sites.

Editor's note: This story was originally published Friday morning, and has been updated to reflect the FDA's decision regarding the drug later that day. A U.S. approval decision for a major drug planned to be marketed by Cambridge-based Sanofi Genzyme that had been expected last Friday has been delayed due to “deficiencies” found during a manufacturing site inspection in France. In its third quarter report, released Friday morning, French drugmaker Sanofi (NYSE: SNY) disclosed that “manufacturing…

Latest innovation in quadrivalent meningococcal vaccination designed for use in persons 2 years of age and older in the U.S.

• Independent Data Monitoring Committee recommended continuing ongoing Phase 3 trial only in the more advanced “critical” group with Kevzara higher-dose versus placebo and discontinuing less advanced “severe” group

- Libtayo decreased the risk of death by 32.4% compared to chemotherapy

There are major regulatory lapses in the manufacturing of similar biologics in India. The use of scientific audits could strengthen the regulatory system and improve the provision of high quality biosimilars in the country, according to a recent opinion piece [1] by Dr GR Soni, which was published in GaBI Journal.

The US Food and Drug Administration (FDA) has approved the first generic version of a commonly used inhaler, marketed as Proventil, and the anti-parasitic Daraprim, which has previously been the subject of a price gouging scandal.