Episcopal Ministries to the Aging Inc., a Maryland not-for-profit corporation that owns skilled nursing facilities, has agreed to pay $1.3 million to the government for submitting false claims to Medicare for unreasonable or unnecessary rehabilitation therapy purportedly provided by RehabCare Group East Inc., a subsidiary of Kindred Healthcare Inc.

Thank you, John, not only for that kind introduction but also for your exemplary leadership as chair of the LSC Board. LSC really exemplifies that spirit Attorney General Robert Kennedy used to talk about – that as lawyers, we have an obligation to enlist our skills and ourselves in engagements that reach beyond the horizons of our parochial legal practices. And over the last five-and-a-half years I’ve served in this Administration, I’ve been fortunate to get to know John and LSC President Jim Sandman, and I know the movement for expanding access to justice in this country is better and stronger because they’re helping to lead this effort, so my thanks to them.

A Detroit-area hematologist-oncologist pleaded guilty today for his role in a health care fraud scheme, admitting that he administered unnecessary chemotherapy to fraudulently bill the Medicare program and private insurance companies. According to court records, the scheme enabled the doctor to submit approximately $225 million in claims to Medicare over six years.

Attorney General Eric Holder is set to announce a partnership between the Department of Justice’s Office of Juvenile Justice and Delinquency Prevention (OJJDP) and the Department of Housing and Urban Development (HUD). HUD will offer new grants to support collaborations between HUD-funded organizations, and civil legal aid programs and public defender offices. The grant funded collaborations will focus on expunging and sealing juvenile records – improving the chances that reentering youth will be able to obtain degrees, find work and secure housing. The announcement is set to be made this evening during the Attorney General’s remarks to the Legal Services Corporation 40th anniversary celebration.

Thank you, Dean [Martha] Minow, for those kind words – and thank you all for being here. I also want to recognize, and thank, my good friends John Levi and Jim Sandman for their leadership of the Legal Services Corporation over the years – and for the lifetimes of tireless work that they have dedicated to vulnerable populations from coast to coast. Finally, I want to thank each and every one of you – the dedicated men and women who are making LSC’s work possible; who are helping to shine a light on the current challenges facing the legal aid community; and who are leading us to redouble our efforts to forge the more just society that all Americans deserve. It’s gratifying to see so many diverse people and interests – from academia and government service, to private practice and corporate enterprise – converging to support equal justice under law.

Attorney General Eric Holder announced today the launch of the Justice Department’s National Initiative for Building Community Trust and Justice.

ALEXANDRIA, Va

By Alice Li, MD, MSc, RAC (CAN), Regulatory Scientist, Cato Research FDA issued “The Abbreviated 510(k) Program – Guidance for Industry and Food and Drug Administration Staff” on 13 September 2019. The content of this guidance supersedes the content from 1998 guidance “The New 510(k) Paradigm – Alternate Approaches to Demonstrating Substantial Equivalence in Premarket …

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By Alice Li, MD, MSc, RAC(CAN), Regulatory Scientist, Cato Research Special Interest Guidances/Information Date Posted Guidance for Industry: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics – Final Guidance 30 Dec 2019 Submission of Plans for Cigarette Packages …

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By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS Special Interest Guidances/Information Date Posted Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Draft Guidance for Industry: Draft Guidance for Industry – Draft Guidance 30 Jan 2020 Arthroscopy Pump Tubing Sets …

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By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS    Special Interest Guidances/Information Date Posted Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency: Immediately in Effect Guidance for Clinical Laboratories and Food and …

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By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS FDA guidances from March 2020 as well as upcoming advisory committee meeting announcements are below.  We note that approximately one-third of FDA’s guidances this past month are related to COVID-19.    Special Interest Guidances/Information Date Posted Enforcement Policy for Gowns, Other Apparel, and …

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By Ashley Henderson, PhD, CATO SMS Scientist 1.0 INTRODUCTION The COVID‑19 pandemic has added an unprecedented set of challenges to the conduct of clinical trials including quarantines, travel limitations, site closures, and interruptions in the supply chain of investigational products. In acknowledgement of these challenges, the Food and Drug Administration (FDA) recognizes that protocol modifications …

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By Zachary Swan, PhD, RAC, Associate Director, Regulatory Affairs at CATO SMS    Special Interest Guidances/Information Date Posted Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency: Guidance for Industry – Final Guidance 30 April 2020 FDA Deems Certain Tobacco Products Subject to FDA Authority, …

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Axsome Therapeutics Inc.'s (AXSM) phase II/III trial of investigational drug AXS-05 in Alzheimer's disease agitation has met the primary endpoint.

Today's Daily Dose brings you news about Blueprint Medicines' disappointing results from gastrointestinal stromal tumor trial; revised timeline of Clearside Biomedical's resubmission of XIPERE NDA; encouraging trial results of INOVIO's MERS coronavirus vaccine and initial data from Syndax Pharma's acute leukemia trial.

The Health Impact Project’s toolkit contains resources that help communities, agencies, and other organizations take action to improve public health. The toolkit offers a collection of health impact assessments, guides, and other research to support policymakers’ efforts to consider health when making decisions across sectors, such as housing, planning, and education.

The coronavirus pandemic has infected more than 2.5 million people worldwide, with the United States accounting for nearly 1 million of those cases.

More than 2 million Americans suffer from opioid use disorder, but only about 25% of people receive any sort of care. For many, inpatient treatment often means leaving a job and loved ones behind to seek recovery.

This blog post was written by Deanna Petersen, CBO of AVROBIO, as part of the From The Trenches feature of LifeSciVC. When AVROBIO went public in June 2018, I found myself on the steep end of an unexpected but interesting

The post Recipe For Managing Data Disclosure Successfully With Academic Partners: A Public Gene Therapy Company Perspective appeared first on LifeSciVC.

innoVactiv announces today its study supporting the efficacy of InSea2® to beneficially affect post-meal cognition and mental energy has been accepted for publication.

InstantGMP, Inc. released a much-anticipated enhancement to the Equipment Logs feature.

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.

In this INSIDER Q&A, experts in contract manufacturing discuss aspects a brand owner should evaluate, what should be outlined in an agreement and what ongoing QA checks to conduct during the partnership.

A comprehensive study on the health needs of Filipino migrant workers has won the inaugural APEC Healthy Women Healthy Economies award.

An APEC Business Travel Card mobile application will make travel easier and more secure

Malaysia, the host of APEC 2020, has announced the postponement of the upcoming Second Senior Officials’ Meeting, the 2020 APEC Tourism Ministerial Meeting, and the 2020 APEC Ministers Responsible of Trade Meeting, which were scheduled for April this year.

Regional cooperation key to containment and rebound

From : Communities>>Regulatory Open Forum
Thank you Dinar! ------------------------------ MARIA GUDIEL Brea CA United States ------------------------------

From : Communities>>Regulatory Open Forum
Thank you Richard! ------------------------------ MARIA GUDIEL Brea CA 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
Hello, If there is a significant change to an accessory cleared under a 510(k) of a product, are we supposed to file a significant change to the FDA for the original 510(k) for the accessory? ------------------------------ Shikha Malik Regulatory Affairs Specialist II Dallas TX United States ------------------------------

From : Communities>>Regulatory Open Forum
Hello Shikha, This depends on whether the form, function, and operation of the medical device is affected by the change to the accessory.  Without knowing the device, the accessory, or the type of change, it is hard to say, but I refer you to the FDA Guidance document for when to complete a 510(k) for an existing device.  If you go through the flowchart and read the descriptors for each there is the item B.5 and then the sub-boxes 1 through 4.  There is the question whether a change to accessory [More]

Anx·i·ety (noun)
The state of uneasiness caused by apprehension of possible misfortune.

Yep.  That’s the word that comes to mind whenever anyone mentions FDA inspections.

But anxiety often stems from a lack of control, and in a regulatory inspection, you have more control than you might think.  There are many steps you can take -- before, during, and even after an inspection is over -- that can give you a fair degree of control over the outcome.   Here, Polaris auditors Lauren Kelley and Michele Commins share some of those steps with you.



Pre-inspection Preparation
For-cause inspections may be unannounced, but routine FDA inspections of submission data are scheduled in advance*.  That means most inspections are not pop quizzes; they’re final exams.
Remember how happy you were when a teacher gave you access to a prior year’s exam to study from?  You knew the type of questions that would be asked.  You knew how to prepare.

So this is the first tip we’d like to share.  FDA has, indeed, given you a copy of their exam in advance, in the form of its Compliance Program Guidance Manual, CPGM 7348.811.  This is the document all FDA field investigators use to conduct inspections at clinical sites.  It outlines in great detail what documents investigators will review, what dates they’re going to verify, what processes they’ll evaluate, what data they’ll collect, and what records they’re going to compare.  Despite its rather uninspired title, this is your copy of the final exam.

You know cramming is a risky strategy, so the earlier you get familiar with the CPGM the better.  Inspection readiness is a state of preparedness more than it is a laundry list of activities; it takes some time to get there.

When the Inspector’s in the House
According to the CPGM, one of the first pieces of information the FDA investigator will obtain is a list of all of the studies performed by the clinical investigator, including protocol number, sponsor, and study dates.  So even though FDA has scheduled its inspection with you, and has told you what study the investigator is coming to inspect, any study is fair game.  An FDA investigator can look at any document she wants, or talk to any staff member he chooses, whether related to the “assigned” study or not.

Most of your preparation will have been study-specific; questions about other studies will catch your staff off-guard, and a review of records for other studies may find them less than inspection-ready.  So here’s our second tip.   Avoid anything that might pique the investigator’s curiosity about a study that is not the original subject of the inspection.  Make sure the room you reserve as your investigator’s “home base” is free of any documents, reports, notes, phone lists, and post-its.  Make sure you tidy up offices, workspaces, and facilities site-wide, and keep extraneous chatter in check.

After the Visit
If your FDA inspection resulted in zero observations, then stop reading, thank your awesome staff members, and go celebrate.  If, however, you did receive a Form FDA 483, it’s probably not the end of the world, but you do have some work to do.  Our third tip is this:  remember that the sponsor/CRO is your ally here.  They have as much invested in FDA’s assessment of your study data as you do, and they have the regulatory, QA, even legal resources that you might not.   You’re not required to formally respond to 483s, but if you do, you’re likely to receive a more favorable Establishment Inspection Report (EIR) in the end.  Let your sponsor/CRO help you with your response.

Tips Do Not a Plan Make
Tips are helpful, but you’ll need more than that to ensure a successful FDA site inspection.  You need an inspection readiness plan -- a plan that you document and keep current.  All site staff members need to train on the inspection procedures and the individual roles they will play.  (Fourth tip: don’t forget to train your temporary employees; an office temp working at the receptionist desk could be the first person your FDA investigator speaks with.)

A Last Thought
Inspections are stress-inducing events, and nervous people make mistakes.  Investigators know this, and expertly exercise the “pregnant pause,” knowing how difficult it is for people to withstand an excruciating silence without volunteering unsolicited information.

So one last tip:  conduct a mock inspection before the FDA comes to visit.  It will stress test your procedures and identify improvements you need to implement.  A thorough mock inspection will give staff members an opportunity to rehearse their roles and interview techniques so they can execute your plan and speak to the FDA investigator with confidence.

_______________________________
* For-cause inspections are also known as Investigator-oriented, and routine inspections are also known as study-oriented.

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

With the COVID-19 impact making itself apparent on a daily basis as the numbers climb and organizations respond, the effects on the pharma and biotech sector also shifts. Yesterday FDA announced a new concentration of agency assets to be focused … Continue reading →

There is going to be a time in the not too distant future, when the fuller picture of the healthcare impacts of COVID-19 come into sharper focus. When that happens, it is not likely to be pretty. In large part, … Continue reading →

Posted by Roger Bate India’s government is contemplating suing my coauthors and I for defamation for some research we published last month. In our National Bureau of Economic Research working paper on the quality of Indian medicines exported to Africa we concluded that poorer quality products were intentionally being sent to Africa because of the continents generally weak oversight of drug quality. Litigation is rarely an effective method of finding the truth, more often a process to li [...]

Posted by Roger Bate A new research paper in Health Affairs suggests that the use of compulsory licenses may not lead to cost savings, when compared with voluntary negotiations. Compulsory licensing (CL) allows low-income countries to break innovator patents and accelerate cheap alternatives, either produced locally or imported. In some cases the price cuts of CL can be substantial, notably in Thailand, where key medicines dropped to about 10% of the original price. But researchers (in [...]

A third of pharmacists cannot obtain continuous supplies of personal protective equipment, according to a survey conducted by the Royal Pharmaceutical Society.

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There has been a surge in demand for gender identity services in the UK over the past five years. Although the current role of pharmacists is limited, their potential contribution within a multidisciplinary team supporting transgender patients is beginning to emerge.

To read the whole article click on the headline

Venture capital firm Frazier Healthcare has grabbed Scott Byrd, Ian Mills, and Gordon McMurray as its new Entrepreneur-in-Residence consultants.

The results provide priceless information on ancestry and predispositions to various illnesses.

After four years of negotiations, European lawmakers agreed on June 15 on a new EU Medical Devices Regulation (MDR). The MDR is the equivalent to the FDA’s CDRH regulations in the United States and essentially specifies the applicable rules when importing medical devices into Europe, which is the world’s second-largest device market. Rules relate, for...… Continue Reading

California DMV will reopen 25 field offices after shutdown

The good news: The state is far better prepared to meet this challenge than it was a decade ago. The bad news: It will need help from the feds, and a lot of it.

A looming recession due to the coronavirus imperils Champagne, buffalo mozzarella and other European delicacies. They're luxuries, but also livelihoods.

By Karla L. Palmer —