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

Read more : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900762SEMINAR?wordpress_seo

GlobalCompliancePanel announces Seasonal offers for Professionals with Flat 50% OFF on all Seminars

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Do celebrations need a cause and a reason? Yes, and GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, is having a solid cause and reason for doing so. It is celebrating the many years of its relationship with its customers spread all over the world by offering its trainings at a massive 50% discount!

Yes, that is right. GlobalCompliancePanel’s seminars will be available for a huge 50% discount till April 30. Regulatory professionals who want to augment their knowledge of regulatory compliance can now do so by paying just half the price of these trainings from GlobalCompliancePanel. All that is needed to do walk away with a rare offer such as this is to visit https://www.globalcompliancepanel.com/seminar?wordpress_SEO and use MGCP50 Promo Code.

This offer is valid till April 30, 2017. Regulatory professionals who want to take any of GlobalCompliancePanel’s trainings can book their trainings for an area of their interest by this date. From April 1 onwards, this offer will cease, meaning that the original price will apply from then.

So, why is GlobalCompliancePanel offering this discount? It is for a simple, but profound reason: It wants to thank its huge customer base for the support they have been extending to this company over the many years for which it has been in business. During the course of the 10 years for which GlobalCompliancePanel has been in business, it has trained thousands of regulatory compliance professionals from around the world.

These professionals, belonging to such varied geographies as the US and Japan and India and Canada, have been able to meet their regulatory compliance challenges on account of these trainings. These trainings are relevant, focused and valuable, and are from some of the best known regulatory compliance Experts found anywhere on this planet.

It is these trainings that have been hoping these professionals in the regulatory compliance arena gain more insights into regulations from the FDA, the EMA and other such bodies around the world. These trainings have been consistently helping them to meet these challenges, as they give them a better and sharper understanding of the implementing these requirements.

These regulatory requirements can pose hurdles to the most experienced and brightest of regulatory compliance professionals in the medical devices, pharmaceutical, life sciences and food and biologicals areas, but not to those who undertake professional trainings from GlobalCompliancePanel. GlobalCompliancePanel’s panel of experts is here to help them overcome these challenges and hurdles.

This trend has been being witnessed from the time GlobalCompliancePanel entered the line of professional trainings. Any wonder then, that no fewer than 50,000 professionals have benefited from these trainings? What could be a better way of thanking such a huge base of customers than with this offer? GlobalCompliancePanel believes that a celebration should also be useful, and this is that this offer is!

Hurry up and enroll today. Happy learning!

 

 

New FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods and adherence to them

The U.S. Food and Drug Administration (FDA) is in the process of finalising food safety rules. A major part of these rules is devoted to the ways by which to ensure scientific and safe transportation and logistics food transportation. The FDA is required to establish rules for that improve, audit and enforce new rules relating to food transportation. This is something required by the Food Safety Modernization Act (FSMA), under congressional instructions.

Many aspects of food transportation come under the ambit of these new FSMA Rules. These include:

–       Foods not completely enclosed by a container

–       Prevention and reduction in adulteration and risk

–       Personnel training and certification for this purpose

–       Inspecting food and collecting data

–       Maintaining compliance and reporting about its evidence.

How to do this right?

Comprehension of all the FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods is necessary and important for organizations that work in food transportation. They also need to know how to implement these rules. It is this understanding that GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will offer at a seminar it is organizing.

The Director of this two-day seminar is John Ryan, President, TransCert, QualityInFoodSafety, RyanSystems. To gain insights into how to understand all the aspects of the FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods and to understand how to comply with them, just register for this session by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900810?wordpress-SEO . This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion

At this seminar, the Director will arm participants with an understanding of the legal requirements of food transportation and how to develop a company plan that meets the expectations and requirements of both its customers and the FDA. Also offered is total understanding and review of the ways of establishing the right temperature monitoring, sanitation, container test and traceability, training and data reporting procedures.

Technological aspects of FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods

Technological aspects of food transportation are gaining importance. These include new low cost GPS enabled traceability and temperature monitoring technology, EPA approved container sanitizers, washout technologies, temperature maintenance equipment, and food residue and bio-contaminant testing. FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods have a close relationship with these. The Director of this seminar will take these up for examination.

In reviewing the future of transportation food safety in the light of new and evolving technologies; the Director will dot the seminar with references to upcoming technology providers and provide Internet links to detailed information on the same.

This seminar is immensely useful for food supply chain logistics and food safety and security personnel whose primary responsibilities include management, sanitation, quality and operations. Those involved with handling incoming and outgoing food shipments, maintaining transportation equipment and tools, and purchasing or selling will also derive high value out of this seminar.

Article on FDA 21 CFR Part 11 Compliance

FDA-regulated industries electronic signatures and other records are considered authentic. From 2007, a strong body of opinion has emerged challenging the stringency of these requirements, but nothing major has been diluted from these.

The regulations under FDA 21 CFR Part 11 Compliance set out criteria that the Food and Drug Agency (FDA) considers in order to deem electronic signatures authentic. The electronic records, electronic signatures, and handwritten signatures executed to electronic records of several FDA 21 CFR Part 11 Compliance sets out benchmarks by which FDA-regulated industries have to be compliant with the standards set out in FDA 21 CFR Part 11 Compliance to prove that these are authentic, safe and trustworthy. The operative factor is that the FDA has to consider these signatures as being on par with those done on paper.

Which industries are included in FDA 21 CFR Part 11 Compliance?

FDA 21 CFR Part 11 Compliance applies to nearly all FDA-regulated industries, including but not restricted to:

  • Medical device manufacturers
  • Drug makers
  • CROs
  • Biotech companies, and
  • Biologics developers

The Aim of FDA 21 CFR Part 11 Compliance

The aim of FDA 21 CFR Part 11 Compliance is to ensure that specified FDA-regulated industries such as those mentioned above (with specific exceptions) implement controls -which could include audits, audit trails, documentation, system validations, and electronic signatures -for software and systems involved in processing electronic data that are:

  • Required to be maintained by the FDA predicate rules or
  • Used to demonstrate compliance to a predicate rule. The FDA describes a predicate rule as any requirement set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA regulation other than Part 11. FDA 21 CFR Part 11 Compliance also applies to submissions made to the FDA in electronic format, such as a new drug application.

Which industries are exempt from FDA 21 CFR Part 11 Compliance?

Interestingly, exceptions are allowed within the same industry, based on the format of filing. For example, while FDA 21 CFR Part 11 Compliance applies to submissions made to the FDA in electronic format; it does not apply to a paper submission for the same made in electronic format, such as fax.

Also, FDA 21 CFR Part 11 compliance is not required for record retention for trace backs by food manufacturers. Similar to the logic used in the mode of filing as noted above; most food manufacturers are not otherwise explicitly required to keep detailed records, but when organizations keep electronic documentation for HACCP and similar requirements; this documentation must meet these requirements.

Learn more on this topic by visiting : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900774SEMINAR?linkedin-SEO

Comprehensive risk management is a must for medical device software

Diligent, complete and correct implementation of risk management of software used in medical devices that takes into consideration the gaps and corrects them from the start of product development is absolutely imperative. This is because of two critical reasons:

  1. Gaps, incorrect or incomplete implementation can retard or delay or make the certification/approval of medical products impossible;
  2. Since most activities are closely linked to the development lifecycle; almost none of it can be retrospectively performed. This renders all activities performed till the identification of gaps useless and redundant; making it necessary to start from the beginning, no matter at what stage an anomaly is discovered.

Embedding software risk management into the bigger scope of overall risk management is the way forward if these fiascos have to be avoided.

Learn the ways of doing it right from start till finish

The proper ways of how to take all the necessary steps for designing, implementing and testing critical medical device software in a regulatory compliant environment will be the learning a two-day, live seminar being organized by GlobalCompliancePanel, a very respected provider of professional trainings for the regulatory compliance areas.

Markus Weber, Principal Consultant with System Safety, Inc., who specializes in safety engineering and risk management for critical medical devices, will be the course Director. To participate in this very important seminar, please log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900681SEMINAR?risk-management-medical-devices-Boston-MA

In line with globally applicable standard requirements

International consensus, reflected in globally applicable standard requirements such as ISO14971 and IEC62304, has led to risk management being a mandatory component of almost any activity in the medical device industry. This course will explain these requirements.

risk-mgmt

Given that software risk management has to be embedded into the bigger scope of overall risk management; Markus will introduce all the steps necessary to design, implement and test critical medical device software in a regulatory compliant environment while adhering to the principles of risk management. In addition, he will also address the system level risk management and the resulting interfaces to software.

Understanding safety assurance cases                       

The ‘Safety Case’ or ‘Assurance Case’ document is a well-established method to collect all safety related information together in one place to comprehensively summarize all risk related activities and to demonstrate the safe properties of a device. Currently only required for FDA infusion pump submissions; this documentation will most likely become mandatory for all devices. This course will introduce the basic concepts and content of safety assurance cases and will illustrate their usefulness for internal and external review of safety related information.

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This seminar will use real-life examples and proven tips and tricks to make the application of risk management a practical and beneficial undertaking. It will address the system level issues of risk management as well as the increasingly important software related issues of critical systems. The concept of an assurance case will be introduced to make the combined effort towards designing, implementing and verifying a safe device transparent. The outcome of this learning is that it will help to comply with regulatory requirements with minimized overhead and resource burden.

 

 

Rule relating to orphan drugs in Japan

Orphan drugs are those that are developed purely to treat rare diseases. The nature of orphan drugs is a little piquant: on the one hand, rare diseases affect very few people, but these cannot be ignored. On the other hand, orphan drugs, since they are so few in number, are not taken up usually by profit-driven organizations because they offer very less scope for large-scale production and monetization.

Different countries such as the US and Japan, and blocs such as the European Union have their own unique rules regarding orphan drugs. Rules relating to orphan drugs in Japan too, have their unique and salient features.

A look at the uniqueness of rules relating to orphan drugs in Japan

Orphan drugs in Japan are governed by five incentives:

  • Subsidies
  • Consultation
  • Tax preferences
  • Priority review
  • Reexamination period review

Briefly, this is how each of these is carried out in practice:

Subsidies:The Japanese government has a fund of close to a billion yen that is used to subsidize orphan drug applicants. This grant, given through the National Institute of Biomedical Innovation (NIBIO), is aimed at helping manufacturers to ease the costs associated with development of orphan drugs in Japan.

Consultation:Under this system, the Japanese government offers priorities for manufacturers of orphan drugs in Japan. Called the Priority Consultation System; this process is offered in two ways:

One, when a sponsor of orphan drugs in Japan approaches the PMDA; the application is never rejected. Clinical data is discussed with each sponsor, at which all the aspects of orphan drugs in Japan are considered. Areas taken up for discussion include the number of patients, the intensity of the disease, the integrity and safety of the data, and so on.

Two, the fee category is also considerably lower for orphan drugs in Japan, with these manufacturers given about 25 percent discount. An application made for developing orphan drugs in Japan is put for consolation with a team of Technical Experts, who are selected from the Office of New Drug Review team, the Office of Cellular and Tissue-based Products Review team, and the Office of Medical Devices Review team. In addition, fee categories are drastically lower for orphan drugs in Japan when they are being developed by small companies or research institutes. These categories have a whopping 90 percent discount.

Tax incentive: Manufacturers involved in developing and manufacturing orphan drugs in Japan are given a 12 percent reduction as tax credits for expenses incurred during the NIBIO subsidy payment period.

Priority review:Manufacturers of orphan drugs in Japan are offered a priority review by the PMDA. While the median standard review time is one year for non-orphan drugs, that for orphan drugs in Japan is nine months.

Reexamination period review: The Reexamination period review for orphan drugs in Japan is also relaxed. It is fixed at eight years for orphan drugs in Japan, while this period is ten years for non-orphan drugs in Japan.

Read More: https://www.linkedin.com/pulse/rule-relating-orphan-drugs-japan-ronald-gardner

Why is Computer System Validation Important in FDA Regulated Industries?

Asking why Computer System Validation (CSV) is important in FDA-regulated industries is like asking why an engine is important to a vehicle.

Before going on to get an understanding of this issue, let us understand that there is a difference between the ways in which the term “validation” is used in the general area of computers and that used in FDA-related circles. In the field of computer science, the term means the ability of software to meet its stated requirements. For the FDA, validation of a computer system incorporates all activities that go into a computer system and these should be documented and made available to the FDA. We could use the word “verification” to associate the same meaning and understanding of what “validation” means to the FDA.

All-encompassing term

The critical importance of computer system validation in FDA regulated industries can be learned from at least two perspectives:

1.    When a company is carrying out systematic CSV; it nips potential serious problems in the bud by preventing software problems from reaching production stages and environments. When a problem in a Life Science software application reaches the production environment, this can lead to serious adverse consequences. On the one side, there is the human element of getting the CSV validation wrong, which can result in serious product consequences, which can be disastrous to the patient’s health; on the other, businesses that get their CSV wrong can also face anything from lawsuits and heavy penalties to having to shut shop permanently. Long drawn out court cases can result in serious problems including bankruptcy.

2.    FDA’s regulations requiring companies to carry out systematic CSV have the effect of law, which means that companies that come under the ambit of the FDA are legally bound to follow the guidelines set out by FDA’s regulations. When companies fail during an FDA audit; it can invite inspectional observations (“483s”) and warning letters.

The most important element of CSV that companies need to bear in mind is that they need to get their validation right alright; they also need to get it right stage by stage. Some companies have tried the short cut method of overlooking or circumventing a step or two. While this may give them short term savings; their long term costs are far higher than these savings.

References:

http://www.stsv.com/pdfs/STS_CSV_article.pdf http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm085281.htm

 

Thanks & Best Regards,
John Robinson
GlobalCompliancePanel
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.
Web: www.globalcompliancepanel.com
Email: john.robinson@globalcompliancepanel.com