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COVID-19: Potency Assay Considerations for Monoclonal Antibodies


Center for Drug Evaluation and Research
FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.
Due to the current public health emergency, FDA is issuing this guidance to assist sponsors in the development of monoclonal antibodies (mAbs) and other therapeutic proteins for use as COVID-19 therapeutics. A critical quality control measure for these products is the development and implementation of a potency assay(s) adequate to ensure that each lot is consistently produced with the potency necessary to achieve clinical efficacy and that such potency is maintained over the shelf life of the product. ....

United States , Guidance Issuing Office , Drug Administration , Docket Number , Drug Evaluation , Coronavirus Disease , ஒன்றுபட்டது மாநிலங்களில் , வழிகாட்டல் வழங்குதல் அலுவலகம் , டாக்கெட் எண் , மருந்து மதிப்பீடு ,

Coagulation Systems for Measurement of Viscoelastic Properties: Enforcement Policy During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency


Center for Devices and Radiological Health
FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.
FDA is issuing this guidance to provide a policy to help expand the availability of coagulation systems for measurement of whole blood viscoelastic properties that are used to assess hemostasis, for the duration of the COVID-19 public health emergency.
This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)). ....

United States , Public Health Service Act , Radiological Health , Human Services , Guidance Issuing Office , Drug Administration , Docket Number , Coronavirus Disease , Federal Register , Making Available Guidance Documents Related , Federal Food , Cosmetic Act , ஒன்றுபட்டது மாநிலங்களில் , பொது ஆரோக்கியம் சேவை நாடகம் , கதிரியக்கவியல் ஆரோக்கியம் , மனிதன் சேவைகள் , வழிகாட்டல் வழங்குதல் அலுவலகம் , டாக்கெட் எண் , கூட்டாட்சியின் பதிவு , தயாரித்தல் கிடைக்கிறது வழிகாட்டல் ஆவணங்கள் தொடர்புடையது , கூட்டாட்சியின் உணவு , ஒப்பனை நாடகம் ,

Providing Regulatory Submissions in Electronic Format --Content of the


Center for Biologics Evaluation and Research
Under section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379k-1(a)), beginning no earlier than 24 months after the issuance of this final guidance in which the Food and Drug Administration (FDA or Agency) has specified the electronic format for submitting certain submission types to the Agency, the content of such submission types must be submitted electronically and in the format specified by FDA. This guidance describes the format requirements for the electronic submission of the content of a risk evaluation and mitigation strategy (REMS) document under section 745A(a) of the FD&C Act. This guidance describes how FDA will implement the requirements for the electronic submission of REMS documents as part of submissions under new drug applications (NDAs), abbreviated new drug applications (ANDAs), and, as described in Section III below, certain biologics license applications (BLAs). Consistent with sec ....

Guidance Issuing Office , Drug Administration , Docket Number , Drug Evaluation , Biologics Evaluation , Federal Food , Cosmetic Act , வழிகாட்டல் வழங்குதல் அலுவலகம் , டாக்கெட் எண் , மருந்து மதிப்பீடு , உயிரியல் மதிப்பீடு , கூட்டாட்சியின் உணவு , ஒப்பனை நாடகம் ,

Review Timelines for Applicant Responses to Complete Response Letters


Center for Drug Evaluation and Research
FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.
FDA is issuing this guidance to provide information pertaining to review timelines that FDA will use during the COVID-19 public health emergency for the following applicant responses to complete response (CR) letters when a facility assessment is necessary before FDA can take action on a marketing application:
Amendments to original and supplemental abbreviated new drug applications (ANDAs) submitted to FDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). ....

United States , Public Health Service , Guidance Issuing Office , Drug Administration , Biologics Evaluation , Drug Evaluation , Coronavirus Disease , Federal Food , Cosmetic Act , Electronic Submissions Intended For , Management Staff , Citizen Petitions , Draft Proposed Guidance Documents , ஒன்றுபட்டது மாநிலங்களில் , பொது ஆரோக்கியம் சேவை , வழிகாட்டல் வழங்குதல் அலுவலகம் , உயிரியல் மதிப்பீடு , மருந்து மதிப்பீடு , கூட்டாட்சியின் உணவு , ஒப்பனை நாடகம் , மின்னணு சமர்ப்பிப்புகள் நோக்கம் க்கு , மேலாண்மை ஊழியர்கள் , குடிமகன் மனுக்கள் , வரைவு ப்ரபோஸ்ட் வழிகாட்டல் ஆவணங்கள் ,

Guidance for Industry: The Use of an Alternate Name for Potassium Chloride in Food Labeling


December 2020
The purpose of this guidance is to advise food manufacturers of our intent to exercise enforcement discretion for declaration of the name “potassium salt” in the ingredient statement on food labels as an alternative to the common or usual name “potassium chloride.”
FDA intends to exercise this enforcement discretion to provide industry with greater flexibility when labeling their food products, including those that are formulated to reduce sodium content. This enforcement discretion may result in manufacturers using potassium chloride as a substitute ingredient for some sodium chloride and may lead to reduced sodium intake.
This guidance is consistent with FDA’s Nutrition Innovation Strategy to reduce the burden of chronic disease in the United States through improved nutrition, by empowering consumers with information, and supporting and fostering industry innovation in developing and promoting healthfulness of food options. This guidance is a ....

United States , Guidance Issuing Office , Drug Administration , Office Of Nutrition , Docket Number , Food Safety , Applied Nutrition , Innovation Strategy , ஒன்றுபட்டது மாநிலங்களில் , வழிகாட்டல் வழங்குதல் அலுவலகம் , அலுவலகம் ஆஃப் ஊட்டச்சத்து , டாக்கெட் எண் , உணவு பாதுகாப்பு , பயன்படுத்தப்பட்டது ஊட்டச்சத்து , கண்டுபிடிப்பு மூலோபாயம் ,