FDA Final Guidance for [Industry]

If a firm disseminates HCEI to this audience, FDA does not intend to consider such information false or misleading.

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FDA recently announced the availability of an important guidance for industry. The document, “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities–Questions and Answers,” updates an Obama era-draft that outlines how companies can communicate off-label health care economic information about their products to drug purchasers like a health plan or a hospital.

Guidance

The guidance, “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities–Questions and Answers,” provides answers to common questions regarding firms’ communications of HCEI (healthcare economic information) about their approved prescription drugs to payors. The guidance also provides answers to common questions regarding firms’ communications of HCEI about their approved or cleared medical devices to payors. In addition, the guidance addresses common questions relating to firms’ dissemination to payors of information about medical products that are not yet approved or cleared for any use and about unapproved uses of approved/cleared medical products.

There are two changes of note in the document. First, the guidance is expanded and includes medical devices along with drugs. Additionally, the guidance applies to communication about unapproved products or unapproved uses of already clearly drugs or devices.

According to FDA Commissioner Scott Gottlieb: “Taking into consideration the many thoughtful comments from stakeholders on our draft guidance, our final guidance now includes recommendations that are designed to enable truthful, non-misleading and appropriate company communications with insurers across a product’s lifecycle. The goal is to advance public health benefits such as increased cost savings from informed and appropriate coverage and reimbursement decisions. In this way, we can help ensure patients have more timely access to cutting-edge medical technologies. We can facilitate access by helping to reduce the overall cost of providing these benefits to patients. And in promoting access, we will advance important public health goals.”

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The guidance specifically addresses how the FDA intends to implement its language for HCEI disseminated in accordance with section 502(a) of the FD&C Act. In particular, FDA notes that an appropriate audience under this section of the law is HCEI that relates to an approved indication and is based on competent and reliable scientific evidence. If a firm disseminates HCEI to this audience, FDA does not intend to consider such information false or misleading.

Furthermore, HCEI should clearly and prominently present the information discussed in the guidance, including study design and methodology, generalizability, limitations, sensitivity analyses, and information relevant to providing a balanced and complete presentation. If HCEI includes material differences from the FDA approved labeling (e.g., new or increased risks, different dosing/use regimens, different endpoints, more-limited/targeted patient populations), it must present “a conspicuous and prominent statement describing any material differences between the health care economic information and the labeling approved for the drug”.

How Simple Techniques were used to Improve Overall Productivity

Manufacturing is one of the premier global industries. It is one of the hallmarks of human advancement in science, and has played a major part in human history. If the dramatic changes in manufacturing processes were the hallmark of the Industrial Revolution, a chain of events that heralded the onset of the modern world that we live in today; the present world is undergoing changes of an unseen magnitude following the emergence of China as a major power, fueled in no small measure by its manufacturing prowess.

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Manufacturing, seen as an industry and in isolation of the important repercussions it has had to history, is a process-driven one, in which constant changes, improvements, innovations and regulations are a given. It is an industry in which millions of people are employed all over the world, and hence, there is an acute need for regulation of safety at the workplace and with the systems. In addition, the techniques employed by this sector can offer scope for a lot of improvement and innovation.

Getting an idea of what manufacturing efficiency means

A manufacturing system that is productive in terms of numbers need not be the most efficient one in terms of safety. A manufacturing line that is busy all the time need not be the most productive of all. Is there a way by which manufacturing can optimize its functions? Is there a way by which workers and professionals in marketing can leverage the industry’s expertise and technologies, and on top of it, their own commonsense, to make a difference into the manufacturing process?

Yes, and a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will show how to do this. The speaker at this webinar is José Mora, a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years, José has worked in the medical device industry specializing in manufacturing, process development, tooling, and Quality Systems.

During his career, he has introduced process performance, problem solving, and Quality System methodologies and has introduced process performance, problem solving, and quality system methodologies. His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopedic implants and instruments, and vascular surgery grafts and textiles.

Please enroll for this webinar by visiting http://bit.ly/2JeP655

Learning packed with real-life examples

At this webinar, José will offer real-life examples and how simple techniques can be used to improve overall productivity without the need to spend weeks performing complex modeling and analysis. He will explain how to identify a constraint in a process by its symptoms, and how to “chip away” at the constraint. He will show how some steps at the constraint can be done by upstream or downstream operations, and will describe the way by which to increase the overall throughput of the production line.

He will give participants an understanding of why measuring operator efficiency at the bottleneck actually adds to the problem, and will show how to overcome these.

This webinar is aimed at benefiting major decision makers in manufacturing, such as Managers, Supervisors, Directors, and Vice-Presidents.

Where does GMP Training end and HR training begin?

HR could be in a predicament about what kind of training to impart to consultants.

That pharmaceutical companies need to hire professionals with the requisite qualifications is beyond question. This is not only required for the smooth conduct of activities in their course of their day-to-day work, but also because the FDA has set out its requirements for the proper educational and skill set qualification of employees in this profession in 21 CFR 211.25(a).

This FDA section underlines the need for educational qualifications, training and experience to carry out their job functions, which cannot be carried out in the absence of these requirements. The consequences of having ill qualified and ill-equipped staff can be of a grave nature. This scenario calls for a thorough look at the way pharmaceutical companies select and train their staff engaged in their work that must incorporate Good Manufacturing Practices (GMPs), while also maintaining quality, which is of paramount importance in this industry, all within the ambit of the organizational culture.

Challenging questions relating to training requirements

Meeting the educational and training requirements for pharmaceutical professions in a GMP environment, while complying with the provisions of 21 CFR 211.25(a) can be quite a challenge for the pharmaceutical companies’ HR. HR training should align with the requirements set out by Quality Assurance. There must be consistency and alignment of the priorities and need of the stakeholders in these two crucial departments.

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HR could be in a predicament about what kind of training to impart to consultants, a practice that is quite prevalent in this industry. Are they to be trained the way regular staff is, or do they have a different set of training requirements? Another practice that abounds in this industry is transferred employees. What about the training for such employees?

Get to understand the elements of onboarding in a GMP environment

A webinar from MentorHealth, a leading provider of professional trainings for healthcare professionals, will be setting doubts relating to all these core areas at rest at a webinar that it is organizing. The speaker at this webinar is Michael Esposito, who has over 30 years of experience in the pharmaceutical industry, during which he has world in a variety of areas including packaging, project administration, Quality Assurance, Government Contracts, translations, systems training, and international operations in many reputable companies such as Wyeth Pharmaceuticals, Pfizer and Johnson & Johnson’s McNeil Consumer Healthcare Division. Michael has more than 17 years’ experience in GMP training and document management.

Please visit http://bit.ly/2HJdw93 to enroll for this very useful session.

Familiarization with the onboarding strategy

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The essence of this webinar is familiarization with the onboarding strategy needed for professionals in the pharma industry. Michael will help participants understand how to put in place an onboarding strategy that combines the inputs of all the major stakeholders and put in place a consistent and comprehensible onboarding and training process that the organization can adapt for its employees.

Participants at this webinar will be able to define the onboarding process in the context of compliance. Michael will help them understand how to interact with HR to create a coordinated onboarding strategy. They will be able to implement a training program that takes into account the differences between the training requirements for full-time employees and contractors, and between new employees and employees transferring internally. They will also be able to prioritize training, so that they not only ensure compliance; they also reduce the learning curve for new or transferred employees.

This session is of value to professionals such as Managers with direct reports, HR professionals, and Quality Assurance and training departments. Michael will cover the following areas at this webinar:

  • FAQs for employee onboarding
  • Management’s expectations for new employees
  • HR onboarding
  • Quality’s role in the onboarding process
  • GMP training requirements
  • Handling full-time employees vs. contractors and other temporary personnel

Benchmarks for training and competency.

How to understand the Pharmaceutical Regulatory Affairs

The important point to note about Pharmaceutical Regulatory Affairs is that it deals with every stage of production.

Regulatory Affairs sit at the center of an industry like pharmaceuticals. Given the importance this industry and the products its manufactures have on the health of human beings; it is imperative that there should be regulations in the industry at every stage of the process of manufacturing and marketing of pharmaceuticals.

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The primary aim of Pharmaceutical Regulatory Affairs is to ensure compliance with regulations that apply to every stage and process of the manufacturing and subsequent activities with the appropriate laws and regulations that apply to the industry.

Pharmaceutical Regulatory Affairs has evolved over a long time

Pharmaceutical Regulatory Affairs, like Rome, was not built in a day. The earliest attempts at making an activity or profession like Regulatory Affairs a discipline in itself can be traced to at least a century. The Diphtheria Epidemic of 1902 and a few other continental and global pharmaceutical disasters in subsequent years, such as the vaccine tragedy, sulfanilamide and thalidomide events made the authorities realize the need for framing initiatives to check the occurrence of such events. Pharmaceutical Regulatory Affairs can be said to have its origins in these events.

pharmaceuticalRegulatoryAffairsEssentially, Pharmaceutical Regulatory Affairs is about providing direction and focus to the strategy, tactics and operations aspects of the industry. It can be termed as a scientific system of surveillance. Pharmaceutical Regulatory Affairs concerns itself with every activity from start to finish and puts regulations in place to ensure that each activity is technically correctly carried out in accordance with these regulations and is in tune with sound scientific principles and practices.

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All round and comprehensive

The important point to note about Pharmaceutical Regulatory Affairs is that it deals with every stage of production, starting with procurement of the raw materials or molecules needed for developing the drug, the clinical trial process, the manufacturing process, the packaging, the marketing and even post-consumption of the product by patients, ensuring that along every step, scientific methods and best practices are adhered to and are in accordance with rules, regulations and requirements set out by the regulatory authorities.

Different set of regulations in different markets

In most cases, it is not only one regulatory body whose regulations and requirements need to be adhered to. When a pharmaceutical product has to be marketed globally, it has to meet the regulatory requirements of all the countries or markets in which it is being sold, individually, unless the rule specifies otherwise.

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In the process of working on all these, the Pharmaceutical Regulatory Affairs profession entails having to take steps to see to it that the product is in some way different from what already exists in the market. All these make Pharmaceutical Regulatory Affairs a challenging profession.

This being the case, Pharmaceutical Regulatory Affairs professionals have their own clearly defined roles on what they need to do in order to ensure that they carry out these activities.

Medical Devices is aimed at ensuring very high quality assurance standards

The logic or the need for process validation for medical devices is spelt out by the FDA.

Process validation for medical devices is a key ingredient of quality assurance in medical devices. Process validation is the criterion for measuring the effectiveness of a quality system for medical devices. The first step that medical device manufacturers have to take to show compliance with regulatory requirements for new and modified existing medical devices is obtaining premarket approvals (PMA) and premarket notifications. Process validation for medical devices is the step that helps them do this.

CFR Part 820, Section 820.75(a)

Process validation for medical devices has to meet requirements set out by the FDA. The FDA’s section which deals with these requirements for process validation for medical devices is CFR Part 820, Section 820.75(a). This section, which deals primarily with process validation for medical devices, requires the validation of the processes that go into the making of a medical device to guarantee a level of assurance that cannot ordinarily be verified by carrying out inspections and tests.

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The reasoning behind process validation for medical devices

The logic or the need for process validation for medical devices is spelt out by the FDA. The underlying principle behind the need for process validation for medical devices is that medical devices validation process should be demonstrable even in the absence of monitoring of the output at a later stage.

That is, process validation for medical devices has to be provable to the extent that it in itself is adequate to show the efficiency of the device, even if later verifications cannot be carried out. This places a heavy onus on the manufacturer for ensuring that the process validation for medical devices is carried out in adherence to strict protocols.

The FDA’s requirement for process validation for medical devices does not stop here. What is narrated above is only the first step. The second aspect of the process validation for medical devices is that it requires process validation where an inadequacy is discovered at a later stage, that is, when the device is out into the market and is being put to actual, real world use. This makes process validation for medical devices all the more complex and totally protocol and process based.

When is process validation for medical devices needed?

The FDA, under CFR Part 820, Section 820.75(a), which deals with the subject, states that process validation for medical devices is needed when:

  • A new product is being manufactured
  • There is a revision into the process being employed for manufacturing this new device or an existing device has a need for a new process
  • A defect gets noticed in the medical device after its release into the market. In such cases, the device has to be recalled and validated all over

Big uses

Although process validation for medical devices is indeed exacting, it is not formulated by the FDA without purpose. Following the set process validation for medical devices has enormous uses, which are very important, considering that medical devices that are not properly validated through a set process have the potential to cause life-threatening damage to people who use them.

Some of the uses of process validation for medical devices:

processValidationForMedicalDevices

An understanding of Pharmaceutical Regulatory Affairs

Pharmaceutical Regulatory Affairs can be said to have its origins in these events.

Regulatory Affairs sit at the center of an industry like pharmaceuticals. Given the importance this industry and the products its manufactures have on the health of human beings; it is imperative that there should be regulations in the industry at every stage of the process of manufacturing and marketing of pharmaceuticals.

pharmaceuticalRegulatoryAffairsThe primary aim of Pharmaceutical Regulatory Affairs is to ensure compliance with regulations that apply to every stage and process of the manufacturing and subsequent activities with the appropriate laws and regulations that apply to the industry.

Pharmaceutical Regulatory Affairs has evolved over a long time

Pharmaceutical Regulatory Affairs, like Rome, was not built in a day. The earliest attempts at making an activity or profession like Regulatory Affairs a discipline in itself can be traced to at least a century. The Diphtheria Epidemic of 1902 and a few other continental and global pharmaceutical disasters in subsequent years, such as the vaccine tragedy, sulfanilamide and thalidomide events made the authorities realize the need for framing initiatives to check the occurrence of such events. Pharmaceutical Regulatory Affairs can be said to have its origins in these events.

pharmaceuticalRegulatoryAffairsEssentially, Pharmaceutical Regulatory Affairs is about providing direction and focus to the strategy, tactics and operations aspects of the industry. It can be termed as a scientific system of surveillance. Pharmaceutical Regulatory Affairs concerns itself with every activity from start to finish and puts regulations in place to ensure that each activity is technically correctly carried out in accordance with these regulations and is in tune with sound scientific principles and practices.

pharmaceuticalRegulatoryAffairs

All round and comprehensive

The important point to note about Pharmaceutical Regulatory Affairs is that it deals with every stage of production, starting with procurement of the raw materials or molecules needed for developing the drug, the clinical trial process, the manufacturing process, the packaging, the marketing and even post-consumption of the product by patients, ensuring that along every step, scientific methods and best practices are adhered to and are in accordance with rules, regulations and requirements set out by the regulatory authorities.

Different set of regulations in different markets

In most cases, it is not only one regulatory body whose regulations and requirements need to be adhered to. When a pharmaceutical product has to be marketed globally, it has to meet the regulatory requirements of all the countries or markets in which it is being sold, individually, unless the rule specifies otherwise.

pharmaceuticalRegulatoryAffairsIn the process of working on all these, the Pharmaceutical Regulatory Affairs profession entails having to take steps to see to it that the product is in some way different from what already exists in the market. All these make Pharmaceutical Regulatory Affairs a challenging profession.

This being the case, Pharmaceutical Regulatory Affairs professionals have their own clearly defined roles on what they need to do in order to ensure that they carry out these activities.

Here the references :

http://www.ijprr.com/File_Folder/127-131%28ijprr%29.pdf

http://www.abpi.org.uk/our-work/mandi/Pages/regulatory.aspx

Army Chief stresses on indigenous defence technology

Good headway has been made in lightweight bullet-proof material and fuel cell technology.

Asserting that there is huge requirement to modernise the armed forces, Army Chief General Bipin Rawat on Monday called for self-reliance in terms of defence equipment manufacturing. Speaking at the Army Technology Seminar in Delhi, General Rawat said: ” the time has come to ensure that we fight the next war with homemade solutions.”
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“There is a huge requirement of modernization of our armed forces, in every field. The future wars will be fought in difficult terrains and circumstances and we have to be prepared for them,” he said.

He also lauded the progress made in the direction of indigenous development of defence technology and called on the industry to strive towards it.
“Good headway has been made in lightweight bullet-proof material and fuel cell technology. The journey has begun and this must continue, we are confident that if we get support from the industry we will walk the extra mile to ensure that we utilize the technology you give us,” he added.
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India has been pushing for ‘Make in India’ initiative in defence manufacturing industry. Defence Minister Nirmala Sitharaman had in December said that the Defence Research and Development Organisation (DRDO) has a great role in realising the ‘Make in India’ vision of Prime Minister Narendra Modi.