What is FDA regulation of combination products?

First, what is a combination product? FDA’s 21 CFR 3.2 (e) describes a combination product as a product that has any of these combinations: a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product.

Lines of distinction are blurring

With the recent technological advancements in the way drugs are combined; there has been a steady increase in the number of combination products the FDA has been getting and expects to receive for review. Historically, the FDA’s medical product centers, such as the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH) have been tasked with the approval of combination products. However, in the near future, FDA regulation of combination products is likely to undergo a vast change, as strict segregation of these bodies has given rise to challenges related to regulation, policy, and review that need to be addressed.

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FDA regulation of combination products covers all aspects of the development and management of combination products, such as clinical investigation, pre-clinical testing, manufacturing and quality control, marketing applications, promotion and advertising,adverse event reporting, and post-approval modifications.

Marketing applications are the backbone of FDA regulation of combination productsFDA regulation of combination products requires all combination products to fulfill marketing applications. This is what enables it to be certified as fit for marketing. A single marketing application or separate one can be made for different parts of the combination product, for its marketing application to get approved.

In most cases, more than one marketing application gets filed when the different parts of the combination product meet different proprietary purposes or serve different kinds of benefits. It is also possible that when any of the individual parts making up a combination product has already been approved for another use, multiple marketing applications are made out as part of FDA regulation of combination products.

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RBI’s latest norms makes Paytm happy, leaves Google, Amazon upset

digital payment industry could be thrown into disarray due to the demand by the Reserve Bank of India (RBI) that all user data be stored within the country, fears an industry grouping, which has termed the decision as “heavy-handed”, even as others, including the country’s largest digital payment provider Paytm, have hailed the move.

In a bid to narrow the growing schism, the industry is planning to send a formal representation to the regulator highlighting its concerns, a top official told ET.

“We are trying to build a consensus on the issue,” said the person adding that the representation to the central bank will be ready this week.

RBI on April 6, mandated all payment companies — global and local—to set up data storage facilities within India by October. The stringent six-month deadline has attracted the ire of several sections of the industry that fear it will lead to a disruption of well-established global networks as well as dampen new innovation in the sector.

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“What RBI is doing is heavyhandedness. A regulator should not bring about such fundamental changes without consultation with a cross section of affected parties,” said Subho Ray, president of Internet and Mobile Association of India (IAMAI).

RBI in its notification said that while the payments ecosystem had grown in India, it needed “unfettered supervisory access” to transaction data to ensure better monitoring of the payment ecosystem. The only exception it gave was for foreign transactions, where the data generated overseas could be stored outside India.

Global technology giants such as Google which offers payment service Tez in India, online retail giant Amazon’s Amazon Pay as well as the payment service from Facebook’s WhatsApp, which leverage the Unified Payments Interface (UPI) —the platform for bank-to-bank micro payments-—could be affected by the move, said industry members, as Indian banks would insist on local hosting of data in order to partner with these firms.

A senior banker, who works very closely on the integration of these platforms with UPI, told ET that they have “had discussions with them ( global technology corporations) already. As of now our stand is that if it affects the payments ecosystem it will affect every global player equally, it will not affect UPI or any payment system alone.”

“We are hoping to get more clarifications from the regulator,” the banker said.

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Google did not reply to ET’s queries. A spokesperson for WhatsApp said the company would not comment as it is reviewing the RBI mandate.

“The problem is not with data localisation but with the process which is being used to implement it,” said Ray of IAMAI, which counts American technology corporations such as Google and Facebook as members.

In contrast, India’s largest digital payment provider Paytm, which is a member of Payments Council of India, which is a part of IAMAI, believes the mandate has come at the right time when payment companies are witnessing unprecedented growth.

“The directive to process and store data only in India will help curb the potential misuse and enable active regulatory monitoring. It will definitely boost customers’ confidence in moving to digital payments without worrying about the security of their personal data,” said Kiran Vasireddy, chief operating officer of Paytm.

Data replication
India has been rocked in recent days by claims that a UK-based analytics firm Cambridge Analytica sourced personal data of users from social network site Facebook without consent.

Paytm, which in addition to offering digital payments is also a licensed payment bank, is already required by law to store all user data within the country.

IAMAI is of the view that the payments industry requires “some kind of data replication,” whereas the RBI is demanding that data be kept only in India. “There is a concept called dual locations, in any case data is kept in multiple locations,” said IAMAI’s Ray.

Bankers that ET spoke to also said that “even if the regulator would have mandated storing data in India along with other data centres for the purpose of scrutiny, it would have been understandable. But to restrict storage in India only is a bigger challenge at this point of time.”

The patient has to use common sense while using FDA dietary supplements

As defined by the American Congress, the term “dietary supplement”, at its most basic, is a product that contains a “dietary ingredient” that is meant to supplement the diet without being the sole ingredient of it. It should be a product a person ingests by mouth. Any of these qualify under the “dietary ingredient” mentioned in the definition: minerals, herbs or other botanicals, amino acids and vitamins. Other substances such as organ tissues, enzymes, metabolites and glandulars also come under dietary ingredients.

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Does the FDA regulate dietary supplements?

No. The FDA does not regulate dietary supplements, but has guidelines by which manufacturers have to ensure that the product is safe for use, does not make false or misleading claims, and complies with the FDA’s requirements in all other respects. However, the FDA does step in to handle cases where there are adverse events or other issues arising out of use of dietary supplements

In this sense, its oversight is vastly different from the regulation it does of pharmaceutical medicines and other healthcare products.FDA dietary supplements also require manufacturers to adhere to guidelines on labelling, which should contain mention of the ingredients in specific format.

Another important element of FDA rules on dietary supplements is that since dietary supplements are not medications per se but are supplements to diets; the FDA expects the user to use her or his discretion in using these. It also suggests that users take medical opinion before consuming FDA-regulated dietary supplements, as too much intake of nutrients can be detrimental to the user.

FDA dietary supplements emergency contact

FDA rule on dietary supplements has an FDA lifeline under the MedWatch program, to which people who experience serious adverse effect should report. They can call up FDA at 1-800-FDA-1088, or fax at 1-800-FDA-0178. They can also report online by visiting the FDA website.

Immunotherapy transforms lung cancer, the biggest cancer killer

Immune therapy drugs can transform lung cancer treatment, giving patients years of extra life, doctors reported Monday.

They found that pre-treating lung cancer patients with immune therapy drugs before they have surgery can help melt away the tumor and at the same time limit or even stop its spread.

And combinations of immunotherapy drugs have helped other lung cancer patients get off more toxic standard chemotherapy while also extending their lives.

The results are so startling that it is likely every lung cancer patient should be given the option of immunotherapy first, said Dr. Roy Herbst, a lung cancer specialist at Yale Cancer Center who was not involved in the studies.

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“I have never seen progress move so fast,” Herbst told NBC News.

 “The results today are really a paradigm shift. They will mean more lung cancer patients getting immunotherapy up front.”

Immunotherapy helps the body’s immune system fight off cancer through a variety of mechanisms: by boosting immune system activity, uncloaking tumor cells and with the use of engineered immune system proteins that very specifically target tumors.

They include the new class of drugs that appear to have stalled former President Jimmy Carter’s melanoma.

The drugs had been shown to help lung cancer, the No.1 cause of cancer death globally and in the United States.

And the new results, released at an American Association for Cancer Research conference in Chicago and published in the New England Journal of Medicine, show more creative use of the drugs could change the way doctors treat lung cancer.

In one study, a team at Johns Hopkins medical school treated 20 patients with one of the immune therapy drugs before they had surgery to remove lung cancer tumors.

A year later, 16 patients were alive and the cancer was still undetectable. Two more had their cancer come back but now have no symptoms after extra treatment. One died of lung cancer and one died of an unrelated head injury. So a year and a half later, 18 of the lung cancer patients are still alive.

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When the medical device company makes patent claims on its process

The Design History File (DHF) is one leg of the all-important triad of documents required for the manufacture of a medical device. While the Design History File is a core requirement set out by the FDA; its counterparts, the Technical File and Design Dossier are required for the EU’s regulatory body, the MDD, and serve the same purpose.

The importance of the Design History File can be gauged from the fact that DHF is a part of the Safe Medical Devices Act passed by the American Congress in 1990 with the intention of establishing standards for safety of medical devices.Design History File is not only required for each and every single type of device; when the medical device company makes patent claims on its process, its development documentation has to be shown to have been followed properly.

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History of the Design History File The FDA’s requirement of a medical device’s Design History File did not appear out of the blue. It developed and evolved over time, mainly as a result of the realization on the part of the FDA that it was at the design and change phases that the device’s problems had been originating, irrespective of whether the device was new or was a changed one.

Analysis over a period of time led to the idea of Design Control. Design Control is a principle by which the design elements of medical devices are tracked, monitored and corrected at every stage, right from beginning till end. Because of this, the Design Control and Design History File have become inseparable twins. A few points corroborating this observation:

  • The DHF is the source that contains or references the records needed for demonstrating that the device’s design is developed in accordance with both the approved design plan and the design control requirements as stated by the FDA
  • Formal and proper Design Control and Design History File are part of the FDA’s Good Manufacturing Practices requirements
  • Design History File combines with Design Control to create another critical yield: the Device Master Record

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These are the core elements of a DHF:

  • The FDA states that the medical device company has to ensure that the Design History File should be a “living document”. This means that it has to contain all the details of the design and development plan. In this, the medical device company should clear state and specify the design tasks and deliverables
  • It should have many copies of the approved design input and design output documents
  • The Design History File should contain the design review documentation
  • It should also document verification and validation
  • In cases where it is necessary, the Design History File should have copies of Design Control documents, apart from the records of change control. The reasons for change should also be stated.

 

Any one heard this, 3 tips can works to loose weight.

Weight loss is still a challenging task for the majority of people trying to shed a few pounds. Science has shown us how diet, exercise, and sleep are keys to successful weight loss as well as maintaining overall health. This article lists three actionable research-based things that should be part of your daily routine if you want to get rid of your belly fat and excess weight.

Losing weight is still a challenging task for the majority of people trying to shed a few pounds. And as more and more people fall short of their weight loss goals, the incidence of obesity continues to grow every year. Being overweight or obese puts you at a higher risk of heart disease, stroke, high blood pressure, diabetes, cancer, breathing problems, gallbladder disease, and gallstones. And the risk is even higher in people with a family history of one of those conditions. A healthy body weight sets the stage for your heart, brain, bones, muscles, and other organs in the body to play their part smoothly and efficiently for many years. Excess weight, especially obesity, drains almost every aspect of health, from reproductive and respiratory function to memory and mood.

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If you are struggling with weight loss even though you think you are doing everything right, chances are you still have not probably figured out the actual culprit that is hampering your efforts. Time and again, science has shown us how diet, exercise, and sleep are keys to successful weight loss as well as maintaining overall health. What people should realise is whether or not they’re doing it right or the healthy way. This article lists three actionable research-based things that should be part of your daily routine if you want to get rid of your belly fat and excess weight.

Exercise

One must exercise enough not just to burn calories for weight loss but to lower the risk of diseases and maintain health. Exercise is also incredibly beneficial for your mental health. It helps you manage stress and can have a profoundly positive impact on depression and anxiety. Studies suggest doing aerobic or cardio exercises regularly can help you burn calories and body fat. Try to include walking, running, cycling and swimming in your fitness regime. While all physical activity helps you burn calories, resistance training – such as weight lifting – can go far beyond that it tones muscle and helps prevent your metabolism from slowing down when you lose fat.

Diet

Many studies have suggested that exercising alone won’t help you lose weight. One reason why exercise alone may not be the key to weight loss is that it often makes you hungrier. Hence, people who only change their exercise habits and not their dietary habits,  don’t see the scale move. To lose weight even faster, experts suggest that your focus should be split in this way: roughly 80 percent focus on your diet and 20 percent on exercise. Here, the logic is that the balance between ‘calories in and calories out’ will decide the final outcome. If you’re watching what you eat and exercising, you’ll probably burn more calories. But that doesn’t mean you should only focus on the calorie count. It is about paying attention to the quality of food you eat. This includes eating lots of fruits and vegetables while refraining from processed foods that are high in sugar, salt, and unhealthy fat. Most fruits and vegetables are low in calories but high in filling fiber and other nutrients that rev up fat loss and improve overall health.

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Which can leave the work of meeting regulatory requirements to FDA Services

FDA consulting services are those services that are offered by independent, mostly private companies in helping to meet FDA requirements. FDA consulting services are offered to organizations that have to meet FDA regulatory requirements. Many companies across the US and many other parts of the world specialize in offering FDA consulting services and these are often the main business for these organizations.

Why do companies offer FDA consulting service?

FDA consulting services are offered because most organizations find the maze of FDA regulation too complex, confusing and time consuming. FDA consulting services are an easy way out for these organizations, which can leave the work of meeting regulatory requirements to FDA consulting services and concentrate on their core areas of business.

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What do FDA consulting services do?

FDA consulting services usually carry out all tasks associated with and required for meeting FDA regulatory requirements. While they may not be involved in the business per se, they help in the documentation part, because this is where their help is required. FDA consulting services help companies in achieving and maintaining all aspects of FDA compliance. This is done for a fee, of course, and is considered legal outsourcing.

In what areas are FDA consulting services offered?

Most FDA consulting services companies offer consulting relating to everything about FDA regulation, although some FDA consulting services companies do so only in select, specialized areas. The services offered by FDA consulting usually include the following:

  • Helping before,during and after an FDA inspection
  • FDA 510(k) Submissions
  • Audits and inspections
  • Audits and gap analysis
  • Writing Standard Operating Procedures (SOPS) forms and reports
  • Form 483 and responses
  • Responses to Warning Letters
  • Investigational Device Exemption (IDE) submissions
  • Serious Adverse Event Reporting
  • Medical Device Reporting

Many FDA consulting services companies offer advice on drugs, dietary supplements, clinical trials, food and tobacco, and medical devices. They also carry out complex tasks like QSR reviews, GCP, GMP, GLP audits, New Drug Application (NDA), Biologic License Application (BLA), Abbreviated New Drug Application (ANDA) and Premarket Approval (PMA), as well as remediation for companies that have to respond at short notice to compliance issues raised by the FDA.