Clinical trials are comprehensive research studies conducted to ensure that recently developed medical interventions, including novel drugs, surgical & other devices, and treatments/ therapies, are safe and effective for human use before commercialization. These trials provide evidence for regulatory bodies like the US Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada, UK’s Medicines and Healthcare Products Regulatory Agency, and China’s National Medical Products Administration (NMPA) to ensure that a specific medical intervention is safe for the public use, begets limited adverse effects, and meets quality standards. However, it takes 10 to 15 years or even more to complete all three clinical trial phases before reaching the licensing stage. Thus, FDA introduced accelerated or expedite approvals to pace up the approval of drugs that treat severe conditions and address unmet medical needs.
Before proceeding with the pros and cons of the FDA’s expedited program, let’s first understand the full-fledged approval process set by various regulatory agencies to launch any novel medical interventions in the market after comprehensive analysis.
- Pre-Approval: the regulatory agencies set specific guidelines around study design, volunteer selection, monitoring procedures, informed consent, and data collection, which pharmaceutical industries must adhere to when conducting clinical trials.
- Investigational New Drug (IND) Application: Drugmakers/ sponsors are obliged to submit an IND application to the regulatory body before initiating a clinical trial. This application comprises justification, proposed study design, safety data from pre-clinical studies, and a feasible approach to monitor volunteers during the trial.
- Review Process: The regulatory agency thoroughly reviews the statistical data, data quality, results of all phases of pre-clinical and clinical trials, and potential benefits & risks associated with the particular intervention.
- Post-Approval: Even after granting approval for marketing and commercializing medical interventions, the regulatory body continues to monitor the safety and efficacy of approved products through post-marketing surveillance and requires periodic reporting of adverse events.
Need for introducing USFDA Accelerated Approval Program
The US FDA’s Accelerated Approval Program (AAP) aims to expedite the development and enable faster access to new therapies that address an unmet need in treating severe ailments. This program is mainly introduced to promote the treatment of chronic diseases, where the course of the condition is extended, and determining the clinical endpoint would take considerable time. The primary objective behind introducing a priority review of specific drugs for accelerated approval is to launch the drugs earlier in the market. To justify, in the case of chronic diseases like HIV and cancer, thoroughly understanding the effect of medications with precision can take a long time, which results in delayed drug approval.
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Learn the first news about what the controversy on the FDA approved marketing of the Contraception App “Natural Cycles” is all about.
Erectile dysfunction (ED) normally known as impotence has been constantly disturbing men over the world since days of yore yet after the passage of Tadalafil 20mg and other ED tranquilizes in the market, the enduring of erectile dysfunction harassed men has significantly reduced.
Without a doubt, Cialis 20 mg and other FDA prescribed hostile to impotency prescriptions are introducing a kind of insurgency on men's sexual health and for this issue; these medications are to be altogether credited.
Beyond what one of these basic issues can aggravate the issue that much.
Luckily there is ED medicines erectile dysfunction fixes that can help.
Erectile dysfunction can be threshold about by numerous variables, including low testosterone levels, thyroid issues, stress, exorbitant liquor use and smoking.
For what reason are these meds more reliable to the erectile dysfunction patients than the other elective medicines of male impotency, for example, penile prosthesis (a particular erectile dysfunction medical procedure), vacuum gadgets, mental treatment and different techniques?
Rising optometric clinical practice is expected to provide an impetus to the growth of the global uveitis treatment market. Growing prevalence of uveitis with the projects on development of biological drugs is expected to fuel the demand for uveitis treatment. In addition, surging prevalence of TB associated intermediate uveitis is further expected to boost the growth of the global uveitis treatment market in the future. Major players in the market are focusing on expanding their product portfolios, enhancing the demand for uveitis treatment.
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Global Uveitis Treatment Market Expected to Witness a Healthy Growth
Research Report Insights (RRI), in its research report, has provided a detailed analysis on the global uveitis treatment market for the forecast period of 2016 to 2024. RRI estimates that the market will grow at a healthy CAGR of 6.5% during the forecast period. Robust emergence of the immunosuppressive therapies for treating uveitis is expected to create new opportunities for leading market players in the future. Surge in autoimmune disorders is expected to primarily drive the demand for uveitis treatment across the globe. Generic drugs have been witnessing a rise in demand, generating opportunities for new as well as established pharma players. Huge investments have been made by several organisations in research and development activities for eye disorders. This is expected to fuel the market growth in the near future.
FDA Approved Adalimumab is Capable of Treating Uveitis
There is no doubt 2016 will be remembered as an innovative year for eye care in pharmaceuticals, and the patients, without doubt, will be the recipients of benefits of these innovations. The approval of adalimumab for treatment of uveitis has led eye care providers to expand the therapeutic armamentarium for managing this destructive inflammatory disease. Food and Drug Administration of the U.S. has approved the utilization of adalimumab in June 2016 for treatment of intermediate, non-infectious, and posterior uveitis, and panuveitis. The decision of regulatory approval was based on results of the two three-phase studies. Both of these studies were placebo controlled and double masked, both enrolling adult patients suffering from active & controlled intermediate non-infectious and posterior uveitis, and panuveitis. Investigators found that the treatment failures in patients treated with adalimumab were significantly lower as compared to those receiving placebo.
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Ribonucleic Acid Interface Therapeutic Agent Developed for Treating Uveitis
A new treatment is expected to eliminate the complications associated with utilisation of steroid in treatment of uveitis. Researchers from Hokkaido University have utilized a new therapeutic agent- ribonucleic acid interface (RNAi) for prevention of ocular inflammation in mice. This development is expected to offer an alternative for treating inflammatory eye diseases with corticosteroids. Long-term usage of these drugs may result into complications such as hypertension, glaucoma, osteoporosis, and cataracts.
The development of new RNAi therapeutic agent safely blocked the ocular inflammation in mice. This is expected to be a new treatment for diabetic retinopathy and uveitis in humans. Researchers were able to depict activation of the receptor-associated prorenin system (RAPS), involving in pathogenesis of uveitis. Scientists came up with the development of an interference agent, targeting this system, and injected it into the mice’s eyes. Significant improvement in the mouse models of chronic diabetic inflammation and acute uveitis was shown by the agent, without any side effects apparently.
The report profiles key market players and highlights their recent activities supporting market growth.
Allergan, Inc., Novartis AG (ALCON), Valeant Pharmaceuticals International, Inc., AbbVie Inc., Eyegate Pharmaceuticals, Inc., Alimera Sciences Inc., and pSivida Corp. are some of the key players in the global uveitis treatment market.
Report Analysis@ https://www.researchreportinsights.com/report/rd/110114945/Uveitis-Treatment-Market
If you are a health care mobile app development company, then you will need to assure the user, that is in your case a patient, that their health records, reports, and other data are to remain completely protected and confidential.
Thus, risk mitigation and high-end data encryption are some of the features that define the high-end operating capabilities of the current bunch of health care mobile apps.
A technology that has been at the forefront since its very inception is Blockchain technology.
Blockchain, with its trademark robust network, is definitely here to stay, and hell healthcare mobile apps function far beyond the user expectations.
It is the result of a lack of medical infrastructure in most places today and has led to serious deterioration of health, in addition to wasting a lot of time and energy of everyone involved.
Internet of Medical Things and Wearable Devices
In case you are thinking about ingesting a prescription diet tablet, there are numerous medicines that the doctor may prescribe.
Phentermine pills are one of the widely used medicines for weight loss.
Adipex-P is the commercial name for Phentermine.
It gained approval from the Food and Drug Administration (FDA) in the year 1959.
It works to decrease your appetite and bring about rapid weight loss in individuals who also follow an exercise program and a low-calorie diet plan.
The global inulin market size that was valued at USD 880.9 million in 2017, is projected to display gradual growth rate during the forecast period owing to favorable effects of inulin in terms of appetite, weight management, and ectopic fat.
Global Inulin Industry, 2015-2025 (Kilo Tons) (USD Million)
Inulin is a type of prebiotic and is mainly composed of fructose.
Studies also found that inulin has a positive effect on insulin resistance helping in maintaining blood sugar level.
For instance, raw chicory root contains 65% of their net weight as fiber and is estimated as a dynamic source inulin.
Inulin is widely used in bakery foods as a prebiotic and high-?ber source, in cereals for crispiness and increase in size, in dairy products for sugar synergy and sweetness, in chocolate as replacement of sugar and fat fiber, and in meat products as a stabilizer and fat replacer.
