A look into the 21st Century Cures Act

Considered one of the most significant changes to be introduced into the American healthcare sector since the passage of the Affordable Care Act; the 21st Century Cures Act was one of the last legislative acts of outgoing president Barack Obama. Signed into law in December 2016; the 21st Century Cures Act seeks to strengthen medical research, foster innovation and accelerate the development of innovative treatments for chronic ailments such as cancer.

The 21st Century Cures Act aims at strengthening funding for the National Institutes of Health (NIH) by allocating over $ six billion to them. Of this, nearly $ five billion will go towards biomedical research funding. One of the highlights of the 21st Century Cures Act is the allocation of nearly $ two billion for the “Beau Biden Cancer Moonshot” initiative, which is in honor of the Vice President Joe Biden’s son, who succumbed to brain tumor.

A different take on health improvement

This approach is a significant one, considering that researchers from some of the nation’s best-known science universities depend on NIH funding for their research. Nearly two thirds of the major drugs that are in the market since 2000 have been the result of NIH research.

In addition, the 21st Century Cures Act will also have a major impact on mental health. This is one of the most notable features of this Act. It allocates over a billion dollars for addressing opioid and other addictions in the US, and the health-related complications that arise from them, which is a significant contributor to the fall in national health standards and productivity of the population in its prime.

Will the 21st Century Cures Act change the FDA approval process?

While addressing this core aspect of scientific research in helping to treat chronic diseases; the 21st Century Cures Act also focuses on another very critical point of medicines: The FDA. Since no drug can ever enter the market without FDA approval and the FDA approval process is very lengthy, expensive and cumbersome; the 21st Century Cures Act seeks to address this fundamental issue by suggesting changes into the approval process for new drugs, as well as medical devices.

Concerns and criticisms

Reservations have been expressed about the effectiveness of the 21st Century Cures Act. The main concern is that the regulatory approval process of drugs from the FDA could get diluted, causing a risk to the lives of the patients, thereby reducing the ability of the FDA to protect lives with its regulations.

There are many issues at stake in this highly important legislation. A webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will discuss the prospects and downsides of this very important law.

At this webinar, John E. Lincoln, a very experienced medical device and regulatory affairs consultant, will offer a complete insight into the provisions of the 21st Century Cures Act. This webinar will be highly meaningful and useful for research institutions and organizations that are directly concerned and connected with the FDA and its administration of emerging technologies and general health. Enroll for this webinar by registering at http://www.compliance4all.com/control/w_product/~product_id=501213?Worpress-SEO

Analysis of all the major aspects of the 21st Century Cures Act

John will explain and analyze all the main areas of the 21st Century Cures Act. He will scrutinize how the Act will concern the FDA, the impact it will have on other areas of the Federal government, and the possible benefits and drawbacks for industries and research institutions that will get directly and indirectly affected by the Act, and the general public.

John will cover the following areas at this webinar:

  • The Act’s 3 Main Areas
  • Increased Funding for Medical Research
  • Speed the Development and Approval of Experimental Treatments
  • Overhaul Federal Policy on Mental Health Care
  • Stated Advantages
  • Concerns Expressed
  • What Has Happened So Far

http://www.foxnews.com/health/2017/01/24/how-21st-century-cures-act-will-save-lives-through-research.html

Getting a grasp of the FDA’s New Enforcement of 21 CFR Part 11

That the FDA has become more rigorous in the enforcement of Part 11 through its new Part 11 and on-going data integrity inspection and enforcement program is evident in this: In just the last three years, it issued more than 30 Warning Letters with Part 11 and data integrity violations. The most common citations are related to not only inadequate integrity, security and availability of electronic records, but also to validation of software and computer systems.

Among the most important questions about the program is what major findings inspectors are looking at. So, companies need to be even more vigilant then before in implementing their electronic records. In view of these developments, it is essential to have in place a proper and foolproof process for ensuring integrity, authenticity and availability of electronic records.

A learning session on understanding the matter

A webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will explain how to achieve all these. Dr. Ludwig Huber, Ph.D., who is Director of Labcompliance, will be the speaker at this session. To understand how to get a grasp of the FDA’s thinking on Part 11 enforcement, please register for this webinar by visiting http://www.compliance4all.com/control/w_product/~product_id=501062

Practical lessons

Dr. Huber will use industry proven case studies on how to avoid 483 inspectional observations and Warning Letters. With this learning, participants will be able to learn how to prepare their organization for trouble-free Part 11 related inspections.

Dr. Huber will set out detailed, six-step plans for helping companies maintain these records. The learning at this webinar will also feature several other strategies and learning experiences to make sure that there will be no surprises should an FDA visit a participant’s company.

Dr. Huber will include three SOPs as an additional bonus to enable easy implementation for participants to this webinar. These are the ones:

o  Checklist: Part 11 compliance

o  Case Studies: How to avoid Part 11 related 483’s and Warning Letters

o  SOP: Electronic Audit trail: Specifications, Implementation, Validation

These are the areas this webinar will cover:

o  FDA’s current inspection and enforcement practices

o  FDA’s new interpretation: learning from FDA inspection reports

o  Strategy for cost-effective implementation of Part 11: A six step plan

o  Recommended changes to existing Part 11 programs to reduce costs

o  Justification and documentation for the FDA and your management

o  Going through case studies from laboratories, offices and manufacturing with graphical workflow of records, step-by-step description, recommendations for individual Part 11 requirements with justifications and documentation for the FDA and your management.

o  Case studies how to avoid or respond to Part 11 related observations with corrective actions to fix current issues and preventive actions to prevent reoccurrence of the same or similar issues.

o  How to prepare your company for Part 11 Inspections.