Understanding the FDA’s Latest Regulations for Computer Systems Used in the Tobacco and Related Industries

 Understanding the FDA's Latest Regulations for Computer Systems Used in the Tobacco and Related Industries1Tobacco, an age-old addiction, dishes out some chilling, unpleasant facts. Tobacco is the US’ leading cause of preventable deaths. Between four and five percent of the entire American population -some 16 million people -live with diseases associated with smoking. Cigarette smoking consumes close to half a million American lives every year, about an eleventh of whom never smoked, meaning that they are second hand smokers who contract diseases just by being in close physical proximity of smokers. The harmful effects of smoking are such that at this current rate of smoking; seven percent of all Americans who are alive today will die a premature death. The average lifespan of a smoker is a good decade shorter than that of a nonsmoker.

The FDA intervenes strongly

Understanding the FDA's Latest Regulations for Computer Systems Used in the Tobacco and Related Industries3

Given the gravity of this situation; the FDA formulated a landmark law in August 2016, which vastly improved and expanded its powers to regulate smoking. It builds on an earlier ruling, The Family Smoking Prevention and Tobacco Control Act of 2009. The law of 2016 arms the FDA with greater powers to enforce laws on smoking, one of the highlights of which is restricting the sale of tobacco products to minors all over the country, since this population is very vulnerable to exposure to smoking.  The FDA now requires proof of age of the buyer of cigarettes, banning the sale of tobacco products through public vending machines, and prohibiting the distribution of free samples to minors.

Other highpoints of this amended legislation include requiring manufacturers of smokeless tobacco products to enter clearer warning signs on the products, requiring them to disclose the contents; strengthens local and state authority in enforcing these laws, and requires manufacturers to provide scientific proof of claims of moderate risk from these tobacco products.

The amended rule aims at hitting producers of tobacco products hard and brings a wide variety of activities under its regulatory net:

  • Mixing e-liquids
  • Manufacturing or modify any type of vaping device
  • Mixing loose tobacco and making it available to smoke in a pipe
  • Rolling or blending tobacco for cigars
  • Manufacturing loose tobacco that enables consumers to roll their own cigarettes
  • Importing of tobacco products
  • Manufacturing of any tobacco product

The FDA’s regulations on cigarettes and other tobacco products also apply to sellers. The main intention of this modified regulation of August 2016 is that it reviews the ingredients of tobacco products that are sold, the ingredients that go into them, and creates awareness of the dangers of these products, all of which were missing in the earlier legislation.

Learning about all aspects of this regulation

Understanding the FDA's Latest Regulations for Computer Systems Used in the Tobacco and Related Industries

A two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will offer a complete explanation of this law. Carolyn Troiano, IT Program Manager and FDA Compliance Consultant, Smart Resources, Inc., who has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries, will be the Director of this seminar. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

This seminar will describe the best practices for developing a compliance strategy, including roles and responsibilities, and the policies and procedures that should be followed to ensure compliance.

Understanding the FDA's Latest Regulations for Computer Systems Used in the Tobacco and Related Industries4

She will cover the following areas at this seminar:

  • FDA Tobacco Control Act
  • Extension of FDA oversight to Vapor, e-Cigarette, Cigar and other industries
  • Details of the August 8, 2016 FDA “Deeming” Regulation
  • Pre-Marketing Tobacco Application (PMTA) Submission
  • FDA Oversight and Compliance Strategy
  • Computer System Validation (CSV) and the System Development Life Cycle Methodology (SDLC)
  • Cost vs. Compliance
  • Policies and Procedures
  • Leveraging Vendors
  • Industry Best Practices
  • FDA Trends.

Understanding the FDA’s Latest Regulations for Computer Systems Used in the Tobacco and Related Industries

 

FDA Finalizes Guidance on Interoperable Medical Devices

On September 6, 2017, FDA finalized a guidance document entitled “Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices” (“Final Guidance”). In the Final Guidance, the agency outlines design considerations for manufacturers when developing interoperable medical devices, as well as recommendations about information to include in premarket submissions and device labeling. Interoperability of devices can encourage the availability and sharing of information across systems, even when products from different manufacturers are used. A draft of this guidance was issued on January 26, 2016.

The Final Guidance defines “interoperable medical devices” as medical devices “that have the ability to exchange and use information through an electronic interface with another medical/non-medical product, system, or device.” These functions can consist of a one-way data transmission to another device or product, or more complex interactions in which command and control is exercised over another device. An “electronic interface” is defined as the medium by which systems communicate with each other, and includes both the type of connection and the information content.

According to the Final Guidance, the agency considers the management of risks associated with an electronic interface incorporated into a medical device to be part of a comprehensive quality system under 21 C.F.R. Part 820. Manufacturers of interoperable medical devices should perform a risk analysis and conduct appropriate testing addressing the risks associated with interoperability, the anticipated users, reasonably foreseeable misuse, and reasonably foreseeable combinations of events that can result in a hazardous situation. In particular, the Final Guidance identifies the following considerations that manufacturers should take into account and “appropriately tailor[]” to the device’s interface technology, intended use, and use environments

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FDA Breaks New Ground With First Approved Gene Therapy for Cancer

FDA Breaks New Ground With First Approved Gene Therapy for Cancer.jpg

When oncologist Dr. Carl June heard the Food and Drug Administration’s decision to bring the first gene therapy to market in the US, he pinched himself, hard.

“It was so improbable that this would ever be a commercially approved therapy,” he said, voice breaking with emotion.

June was referring to a revolutionary cancer therapy that he helped bring from lab bench to market. Co-developed with the drug giant Novartis, the therapy, CAR-T, genetically alters a patient’s own immune cells to target and destroy cancer cells.

Recently, in a historic decision, the FDA threw their support behind Kymriah (tisagenlecleucel), a “living drug” that is designed to treat blood and bone marrow cancer in children that, even with aggressive chemotherapy, is often lethal.

An entire process rather than a packaged pill, the therapy harvests a patient’s own immune cells—T cells that patrol and destroy abnormal cells—retrains them with extra bits of genetic code, and turns them into torpedoes aimed at cancerous cells once reintroduced into patients’ bodies.

“We’re entering a new frontier in medical innovation with the ability to reprogram a patient’s own cells to attack a deadly cancer,” said FDA Commissioner Dr. Scott Gottlieb in a statement, adding that the therapy is “the first gene therapy available in the United States.”

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FDA advisors give a thumbs-up to GlaxoSmithKline’s shingles vaccine

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GlaxoSmithKline’s shingles Shingrix vaccine received an unanimous vote of support by a Food and Drug Administration advisory committee Wednesday on safety and effectiveness to be used in adults 50 and older.

A decision by the FDA to commercialize Shingrix is expected later this year. The agency usually follows the recommendations of its advisory panels.

GSK said in June that the vaccine produced a strong immune response in adults 65 and older who had previously been vaccinated against shingles with Merck’s vaccine, Zostavax. Scientific data published in the New England Journal of Medicine showed that the effectiveness of Merck’s vaccine wanes over time, while GSK’s vaccine appeared to have longer-lasting protection.

GSK said data show that people who received Merck’s vaccine, the only one approved now for the herpes zoster (shingles) vaccine, can later receive the Shingrix vaccine safely and effectively.

“The risk of developing shingles increases with age and it is estimated that up to one in three people in the United States will develop shingles,” said Emmanuel Hanon, GSK head of vaccines research and development. “Today’s vote brings us one step closer to approval of Shingrix, which is specifically designed to overcome age-related weakening of the immune system.”

 

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Applied Statistics for FDA Process Validation

The pharmaceutical industry considers Applied Statistics for FDA Process Validation to be of very high importance. In 2011, the FDA set out this guidance for the industry. as part of this guidance, called “Process Validation: General Principles and Practices”, which sets the framework for Process Validation in the pharmaceutical industry, any organization in the pharmaceutical industry has to set up a three-stage process.

These are the three stages:

I.           Process Design

II.           Process Qualification, and

III.           Continued Process Verification.

Stage 1, or what is called the Process Design stage, is the stage in which the commercial manufacturing process is defined. This definition is based on knowledge gained through development and scale-up activities.

Stage 2, called the Process Qualification, is the stage in which an evaluation is made of the process design to determine if the process is capable of reproducible commercial manufacturing.

Stage 3, the Continued Process Verification, is meant for giving ongoing assurance during routine production to ensure that the process remains in a state of control.

A seminar on the ways implementing Applied Statistics for FDA Process Validation

GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will be organizing a two-day seminar in which the ways of using Applied Statistics for FDA Process Validation will be taught. Richard Burdick, Emeritus Professor of Statistics, Arizona State University (ASU) and former Quality Engineering Director for Amgen, Inc., will be the Director of this seminar on applied statistics for FDA Process Validation.

In order to learn Applied Statistics for FDA Process Validation in-depth, please register by visiting Applied Statistics for FDA Process Validation. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

A detailed and methodical approach to implementing statistical methodologies

This two-day course on Applied Statistics for FDA Process Validation will focus on the ways by which a systematic approach to implementing statistical methodologies into a process validation program consistent with the FDA guidance can be established.

Beginning with a primer on statistics, Dr. Burdick will explain how the methods of Applied Statistics for FDA Process Validation seminar can be applied in each remaining chapter.

Dr. Burdick will next move on to explaining the two fundamental requirements for Process Validation, namely the application of statistics for setting specifications and assessing measurement systems (assays).

He well then show how to apply statistics through the three stages of process validation as defined by requirements in the process validation regulatory guidance documents.

Given that the methods taught through all these three stages are recommended by regulatory guidance documents; this seminar on Applied Statistics for FDA Process Validation will provide references to the specific citations in the guidance documents.

This seminar on Applied Statistics for FDA Process Validation will lead participants into ways of establishing a systematic approach to implementing statistical methodologies into a process development and validation program that is consistent with the FDA guidance.

All-round learning related to Applied Statistics for FDA Process Validation

Dr. Burdick will teach participants how to:

o  Apply statistics for setting specifications

o  Assess measurement systems (assays)

o  Use Design of Experiments (DOE)

o  Develop a control plan as part of a risk management strategy, and

o  Ensure process control/capability.

All concepts at this Applied Statistics for FDA Process Validation seminar are taught within the three-stage product cycle framework defined by requirements in the process validation regulatory guidance documents.

Although established for the pharmaceutical industry, this seminar on Applied Statistics for FDA Process Validation also provides a useful framework for other related industries.

In this important learning on Applied Statistics for FDA Process Validation; Dr. Burdick will cover the following areas:

o  Apply statistics to set specifications and validate measurement systems (assays)

o  Develop appropriate sample plans based on confidence and power

o  Implement suitable statistical methods into a process validation program for each of the three stages

o  Stage 1, Process Design: utilize risk management tools to identify and prioritize potential critical process parameters; and define critical process parameters and operating spaces for the commercial manufacturing process using design of experiments (DOE)

o  Stage 2, Process Qualification: assess scale effects while incorporating large (pilot and/or commercial) scale data; develop process performance qualification (PPQ) acceptance criteria by characterizing intra and inter-batch variability using process design data and batch homogeneity studies; and develop an appropriate sampling plan for PPQ

o  Stage 3, Continued Process Verification: develop a control plan as part of a risk management strategy; collect and analyze product and process data; and ensure your process is in (statistical) control and capable.

A Tour of the FDA 2017

Businessman uses smart watch and phone.

A tour of the FDA is something like a snapshot of what the FDA does. The importance of the FDA can never be understated: It regulates products from the proverbial pin to airplane in the food, medical devices, pharma and healthcare industries, which touch almost every aspect of American lives. The products that the FDA regulates account for about a trillion dollars, which make up about a quarter of all goods traded in the US.

So, what is a tour of the FDA like?

A tour of the FDA helps to get a broad understanding of the this regulatory body and get some idea of the various departments it has, as well as the functions of these departments. To get an understanding of what the FDA does, a reference to its mission statement could give some direction:

“(The) FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.” This is just the opening line of the FDA’s mission statement. Reference to its other statements, which have now included a reference to containing terrorism, will serve as a good guide to a tour of the FDA. In short, the FDA regulates nearly every item used and consumed by the American public.

The history of the FDA

The legal sanction for carrying out its mission is mandated by the Federal Food, Drug and Cosmetic Act (FD&C Act). An amazing fact that a tour of the FDA reveals is that it is one of the oldest regulatory bodies in the world, with its earliest jurisdiction having covered regulation of drugs in the year 1848. The Department of Agriculture, to which President James Polk appointed noted chemist Charles Wetherill, can be considered the earliest endeavor to regulate medical products of daily use in the US.

How is the FDA organized?

A tour of the FDA is incomplete without a reference to the way it is organized. Its structure consists of this hierarchy:

  • Office of the Commissioner
  • Office of Foods and Veterinary Medicine
  • Office of Global Regulatory Operations and Policy
  • Office of Medical Products and Tobacco
  • Office of Operations

Under these broad heads, a tour of the FDA shows the way into which it is divided into several offices and organizations. Important among these include:

  • Office of Regulatory Affairs (ORA)
  • Center for Food Safety and Applied Nutrition (CFSAN)
  • Center for Drug Evaluation and Research (CDER)
  • Center for Biologics Evaluation and Research (CBER)
  • Center for Devices and Radiological Health (CDRH)
  • Center for Devices and Radiological Health (CDRH)
  • National Center for Toxicological Research (NCTR)

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The FDA’s requirements for Drug Applications and Submissions

The FDA has set out requirements by which it accepts drug applications and submissions. It accepts drug applications and submissions through two formats, the New Drug Application (NDA) and Abbreviated New Drug Application (ANDA). The NDA and the ANDA are the mediums through which the FDA eventually approves drug applications and submissions.

The NDA process

The NDA is one the two mechanisms through which the FDA accepts drug applications and submissions. This application is available with the FDA. Any sponsor of a clinical study, be it an organization or an individual, can apply for the NDA and can submit the same, when it is convinced that it has sufficient evidence that its study meets the FDA’ requirements for marketing approval.

The way to go about filing for an NDA as part of drug applications and submissions is this:

The ANDA process

The ANDA is the other method of drug applications and submissions to the FDA. Being the counterpart of the NDA; the ANDA is the application a company makes for getting a generic drug approved by the FDA for marketing. The ANDA also has to contain the same data as contained in the NDA drug applications and submissions, but is not required to be accompanied by the data of the clinical research. It is for this reason that they are called by their name.

In place of the clinical research data, the ANDA format of drug applications and submissions has to contain evidence that the product has the ability to perform the same functions of the original drug. This is called the drug’s bioequivalent value. Like in the case of the NDA, the ANDA too is allocated a reference number as part of its drug applications and submissions.

Common factors taken into consideration

In either of these methods, the primary considerations for the FDA include the following:

  • The safety and effectiveness of the drug
  • Its ability to meet its intended use
  • Its ability of its benefits to outweigh its risks
  • The appropriateness of the drug’s planned labeling and its contents
  • The ability of the methods used in the manufacturing of the drug to meet Good Manufacturing Practice (GMP)
  • The capacity of the drug to have to controls in place for maintaining its quality, purity, strength and identity

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