FDA News Release – Traininng.com

FDA approves treatment for two rare types of non-Hodgkin lymphoma

The U.S. Food and Drug Administration today approved Poteligeo (mogamulizumab-kpkc) injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. This approval provides a new treatment option for patients with MF and is the first FDA approval of a drug specifically for SS.

“Mycosis fungoides and Sézary syndrome are rare, hard-to-treat types of non-Hodgkin lymphoma and this approval fills an unmet medical need for these patients,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “We are committed to continuing to expedite the development and review of this type of targeted therapy that offers meaningful treatments for patients.”

Non-Hodgkin lymphoma is a cancer that starts in white blood cells called lymphocytes, which are part of the body’s immune system. MF and SS are types of non-Hodgkin lymphoma in which lymphocytes become cancerous and affect the skin. MF accounts for about half of all lymphomas arising from the skin. It causes itchy red rashes and skin lesions and can spread to other parts of the body. SS is a rare form of skin lymphoma that affects the blood and lymph nodes.

Poteligeo is a monoclonal antibody that binds to a protein (called CC chemokine receptor type 4 or CCR4) found on some cancer cells.

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm616176.htm

FDA approves first generic drug under new pathway aimed at enhancing market competition for sole source drugs

The U.S. Food and Drug Administration today approved several strengths of potassium chloride oral solution as the first generic drugs to receive a Competitive Generic Therapy (CGT) designation. This new approval pathway was created to expedite the development and review of a generic drug for products that lack competition. Potassium chloride is an oral treatment that is indicated for the treatment and prevention of hypokalemia (low potassium blood levels) in patients who are on diuretics, and when dietary management with potassium-rich foods is insufficient or diuretic dose reduction is not possible.

“Today’s approval marks the successful implementation of a new program designed to encourage generic drug development for products with inadequate generic competition,” said FDA Commissioner Scott Gottlieb, M.D. “The quick implementation of this new pathway is part of our broader effort to foster generic competition and help address the high cost of drugs. So are our efforts to narrow the time it takes for generic drugs to reach the market by reducing the number of review cycles that generic applications typically undergo. This new generic drug application was also approved in its first cycle of review. This approval demonstrates that the competitive generic therapy pathway is efficient and open for business. This pathway is a key step in making safe and effective generic drugs available to patients quickly and ensuring there’s adequate competition so patients have affordable access to the treatments they need.”

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm616167.htm

FDA alerts healthcare providers, women about risks associated with improper use of rupture of membranes tests

The U.S. Food and Drug Administration today alerted women and their doctors about serious adverse events related to the improper use of tests intended as an aid in detecting if a pregnant woman’s water has broken (also known as a rupture of the membranes containing amniotic fluid). A rupture of the membranes (ROM) can pose immediate and severe risks to the patient and developing fetus without proper patient management and timely intervention.

As part of the agency’s commitment to transparency in notifying the public about potential public health concerns, the FDA issued a Letter to Health Care Providers to remind providers that the labeling for these tests specifies that they should not be used on their own to independently diagnose a ROM in pregnant women. These tests have only been cleared for marketing by the FDA to be used by healthcare providers in conjunction with other clinical assessments to make critical patient management decisions regarding whether a ROM has occurred.

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm616137.htm

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GDPR – European Privacy Regulation What and How

The GDPR (General Data Protection Regulation) compels companies that process Personally Identifiable Information (PII) of European citizens to demonstrate their insight in all PII processing going on in their business. After assessment by a Data Protection Officer (DPO), they should implement appropriate organizational and technical controls.See more

Consequences of noncompliance are:

  • High fines, up to 20 million Euro
  • Lawsuits
  • (Personally) liability cases
  • Reputation loss

Benefits of compliance:

  • Insight in PII processing within the company
  • Security Controls up to level
  • Increasing Customer Trust

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Why us? | World Class Regulatory Experts | Seminars | Webinars | Recorded – Traininng.com LLC

Traininng.com is an accomplished and industry-recognized provider of best-in-class professional trainings for the regulated areas. Our experts are sourced from around the world for their expertise, knowledge and experience in helping you understand the nuances of regulatory compliance.

Addressing pain areas

Traininng.com’s objective is to help you overcome the barriers to regulatory compliance and meet regulatory expectations. The modes of our training are chosen to facilitate the closest interaction with the experts and address specific pain areas. Our experts help you meet regulatory requirements and expectations and reduce the exorbitant costs of noncompliance.

Advantages of Traininng.com training

world class online professional training in the areas of regulatory compliance and healthcare
world class online professional training in the areas of regulatory compliance and healthcare

Regulatory compliance is a major activity for organizations in the regulated areas. Staying compliant is expensive, but the cost of lack of compliance is unimaginably higher and goes beyond the monetary aspects. It could range from seven-figure fines and penalties to imprisonment to closure of business.

By bringing world-class experts in the respective areas of regulatory compliance, Traininng.com bridges the crucial gap in regulatory compliance implementation in a very cost-effective manner.

Regulatory trainings vs. compliance automation

Regulatory compliance automation is a great tool for saving manpower and ensuring accuracy, but these are far more expensive than traditional methods. Moreover, most software systems take high additional costs and time to accommodate changes that regulations frequently bring in.

By bringing compliance professionals in direct contact with regulatory experts, we help companies overcome this problem at a fraction of the cost of software implementation. You can keep coming back to our experts to have any additional or new changes or updates clarified and implement them in quick time.

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world class online professional training

We bring to you experts from all over the world in helping resolve issues and pain areas relating to regulatory compliance. Many of our experts have worked with the regulatory agencies or have been part of the teams that have drafted these regulations. They carry many years of experience and expertise, which help you get the right professional help.

These are some of our experts:

Teri C. Soli: T.C. Soli, is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. Dr. Soli is a recognized global expert in contamination and biofilm control in the biopharmaceutical, medical device, and personal care product industries and has authored numerous articles in Pharmacopeial Forum, Pharmaceutical Engineering, and Pharmaceutical Technology, as well as other publications and has authored chapters in many books and industry guides published by PDA and ISPE.

John E. Lincoln: A senior medical device and regulatory affairs consultant, John has helped companies to implement or modify their GMP systems and procedures, product risk management, and FDA responses.  He has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and have been described in peer-reviewed technical articles, and workshops, worldwide.

Robert J. Russell: Robert is President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance.

Ludwig Huber: Dr. Ludwig Huber, Ph.D., is the director and editor of Labcompliance, the global online resource for validation and compliance. He is the author of the books, Validation and Qualification in Analytical Laboratories and Validation of Computerized Analytical and Networked Systems, Informa Healthcare. He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world.

David Nettleton: David Nettleton is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is “Risk Based Software Validation – Ten Easy Steps” that relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications. He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. He has completed more than 185 mission critical software validation projects.

David Drury: Oil and Gas Consultant at Infosphere Ltd., Dr. David Drury is an independent consultant specializing in the commercial aspects of the natural gas business. His areas of expertise include gas and LNG markets, sales and pipeline contracts, pricing and business structures. He has been a commercial advisor on LNG export and import projects in many parts of the world, including Australia, the USA, Russia, Indonesia, Qatar, North and West Africa, Europe and South America.

Features of Traininng.com trainings

Traininng.com offers professional trainings in all areas of regulatory compliance. These trainings are very flexible, pertinent and timely. They are taught through simple and easy to access modes: See more About us

Webinars: Offered online in short durations of around 60-180 minutes, these webinars can be taken up from the convenience of the learner’s desk.

Seminars: In person, live seminars from Traininng.com bring experts to a venue of convenience to the professionals. Traininng.com’s seminars are usually spread over one to three days.

Recorded webinars: Traininng.com also offers recorded webinars, which can be bought once and viewed for an unlimited number of times for one year from the date of purchase.

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Traininng.com offers professional trainings in all the areas of regulatory compliance, including, but not limited to:

 

 

 

 

 

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FDA approves new drug to treat endometriosis pain

A new treatment for pain caused by endometriosis was approved Tuesday by U.S. regulators.

The common condition involves abnormal tissue growth from the uterus that can cause severe pain and infertility.

Professional Trainings Provider

Drugmaker Abbvie said the Food and Drug Administration approved the drug, Orilissa, for pain during menstruation and intercourse and at other times. Abbvie says it’s the first new pill for endometriosis in a decade.

In testing, it significantly reduced menstrual pain in about 45 percent of women given a low dose and 75 percent given a high dose, compared to about 20 percent of women given dummy pills. Reduction of pain outside menstruation was slightly lower.

The drug works by reducing production of the hormone estrogen. That caused side effects in some participants, including hot flashes, headaches and bone thinning.

Orilissa will cost $845 every four weeks, without insurance.

An estimated 1 in 10 women of reproductive age has endometriosis. Treatment usually begins with over-the-counter pain relievers, opioid painkillers and birth control pills. Other options include injections of hormone-suppressing drugs, which have significant side effects, and surgery.

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Key ingredient in ‘Impossible Burger’ approved by FDA

  • The FDA approved the use of soy leghemoglobin, which releases a protein called heme that gives the meat substitute its distinctive blood-like color and taste.
  • It’s a big win for the start-up, which has prominent backers like Bill Gates and Google Ventures.
  • Impossible Foods has recently expanded overseas into the Hong Kong market.

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The Food and Drug Administration has approved the key ingredient in the vegetarian-friendly Impossible Burger. It’s a big win for Silicon Valley-based Impossible Foods as it expands its distribution.

The ingredient, soy leghemoglobin, releases a protein called heme that gives the meat substitute its distinctive blood-like color and taste. Just as the Impossible Burger was gaining in popularity and reach, The New York Times published a report last year revealing that the FDA was concerned that the soy-based ingredient had never been consumed by humans.

In a letter to Impossible Foods released Monday, the FDA deemed soy leghemoglobin GRAS, or generally recognized as safe, in its most recent review.

 

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