510(k) Submission Stages
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Some of the applicants will do pre-submission to FDA to avoid any undue surprise rejection in the last stage. Careful planning, strategic decisions, and expertise of our consultants will ensure the early acceptance of the 510(k) file without RTA or AI and the successful clearance of the 510k submission.
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c) 510(k) submission process
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Treatment Options
Endocrine Therapy
Endocrine therapy is the cornerstone of treatment for HR+ breast cancer in postmenopausal women. The primary goal is to reduce the levels of estrogen or block its effects on cancer cells. Commonly used agents include:
Selective Estrogen Receptor Modulators (SERMs): Tamoxifen is a SERM that binds to estrogen receptors, blocking estrogen from stimulating breast cancer cells. It is effective but may have side effects such as increased risk of endometrial cancer and thromboembolic events.
Aromatase Inhibitors (AIs): These drugs, including anastrozole, letrozole, and exemestane, lower estrogen levels by inhibiting the aromatase enzyme, which converts androgens to estrogen in peripheral tissues. AIs are generally preferred in postmenopausal women due to their efficacy and safety profile compared to tamoxifen.
Selective Estrogen Receptor Downregulators (SERDs): Fulvestrant is a SERD that degrades estrogen receptors and is used in cases where resistance to other endocrine therapies develops.
Combination Therapies
Combining endocrine therapy with other treatments enhances efficacy. Examples include:
Endocrine Therapy with CDK4/6 Inhibitors: Palbociclib, ribociclib, and abemaciclib are CDK4/6 inhibitors that, when combined with endocrine therapy, significantly improve progression-free survival in advanced HR+ breast cancer.
Endocrine Therapy with mTOR Inhibitors: Everolimus, an mTOR inhibitor, can be added to endocrine therapy for patients who have developed resistance to aromatase inhibitors.
Chemotherapy
Chemotherapy is generally reserved for patients with high-risk features, such as large tumor size, high-grade histology, or extensive lymph node involvement. Regimens often include anthracyclines and taxanes.
Nano-gold for Cancer Therapy chemistry investigatory project
chemistry investigatory project
The development of nanogold-based cancer therapy could revolutionize oncology by providing a more targeted, less invasive treatment option. This project contributes to the growing body of research aimed at harnessing nanotechnology for medical applications, paving the way for future clinical trials and potential commercial applications.
Cancer remains one of the leading causes of death worldwide, prompting the need for innovative treatment methods. Nanotechnology offers promising new approaches, including the use of gold nanoparticles (nanogold) for targeted cancer therapy. Nanogold particles possess unique physical and chemical properties that make them suitable for drug delivery, imaging, and photothermal therapy.
How to Control Your Asthma Tips by gokuldas hospital.
Respiratory issues like asthma are the most sensitive issue that is affecting millions worldwide. It hampers the daily activities leaving the body tired and breathless.
The key to a good grip on asthma is proper knowledge and management strategies. Understanding the patient-specific symptoms and carving out an effective treatment likewise is the best way to keep asthma under control.
The Nervous and Chemical Regulation of Respiration
These lecture slides, by Dr Sidra Arshad, offer a simplified look into the mechanisms involved in the regulation of respiration:
Learning objectives:
1. Describe the organisation of respiratory center
2. Describe the nervous control of inspiration and respiratory rhythm
3. Describe the functions of the dorsal and respiratory groups of neurons
4. Describe the influences of the Pneumotaxic and Apneustic centers
5. Explain the role of Hering-Breur inflation reflex in regulation of inspiration
6. Explain the role of central chemoreceptors in regulation of respiration
7. Explain the role of peripheral chemoreceptors in regulation of respiration
8. Explain the regulation of respiration during exercise
9. Integrate the respiratory regulatory mechanisms
10. Describe the Cheyne-Stokes breathing
Study Resources:
1. Chapter 42, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 36, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 13, Human Physiology by Lauralee Sherwood, 9th edition
Skin Diseases That Happen During Summer.
Summer is a time for fun in the sun, but the heat and humidity can also wreak havoc on your skin. From itchy rashes to unwanted pigmentation, several skin conditions become more prevalent during these warmer months.
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510(k) Submission Stages
- 2. STAGES OVERVIEW 2 7 6 5 4 3 Identification Testing Initialsubmission 510(k) clearance Additionalinformation request Initialdetails Documentation 2 1
- 3. STAGE 1- IDENTIFICATION ▰ Classify the medical device and check if it requires 510(k) ▰ Identify the product code and regulation number ▰ Complete establishment registration and device listing 3
- 4. STAGE 2- INITIAL DETAILS ▰ Finalize Indications for Use ▰ Select predicate device to establish substantial equivalence ▰ Identify clinical and non-clinical tests required 4
- 5. STAGE 3- TESTING Initiate testing as per applicable standards ▰ Biocompatibility testing to demonstrate safety ▰ Performance testing to prove effectiveness ▰ Clinical testing (if required) 5
- 6. STAGE 4- DOCUMENTATION ▰ Prepare 510(k) file. For more details refer https://www.fda.gov/medical-devices/premarket- notification-510k/content-510k ▰ Include supporting information like device drawing, manufacturing flowchart, test protocols and reports, labelling etc. 6
- 7. STAGE 5- SUBMISSION TO FDA ▰ Pay 510(k) review fee ▰ Submission of 510(k) file for substantive review 7
- 8. STAGE 6- ADDITIONAL INFORMATION ▰ FDA may request additional information (AI) after review by day 60. AI response includes: ▰ Justification for questions raised by FDA ▰ Corrections made as per FDA suggestions 8
- 9. STAGE 7- 510(K) CLEARANCE ▰ If substantial equivalence established, 510(k) clearance is granted by FDA 9
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