Health

Data Standards for Drug and Biological Product Submissions Containing Real-World Data

Data Standards for Drug and Biological Product Submissions Containing Real-World Data

1 day ago
FDA In Brief: FDA Announces Investigation of Salmonella Outbreak Linked to Whole, Fresh Onions

FDA In Brief: FDA Announces Investigation of Salmonella Outbreak Linked to Whole, Fresh Onions

2 days ago
Outbreak Investigation of Salmonella Oranienburg: Whole, Fresh Onions (October 2021)

Outbreak Investigation of Salmonella Oranienburg: Whole, Fresh Onions (October 2021)

2 days ago
Atlas Pharmaceuticals, LLC, Phoenix, AZ. 483 issued 05/21/2021

Atlas Pharmaceuticals, LLC, Phoenix, AZ. 483 issued 05/21/2021

2 days ago
Colonia Care Pharmacy, Colonia, NJ. 483 issued 07/26/2021

Colonia Care Pharmacy, Colonia, NJ. 483 issued 07/26/2021

2 days ago
Integrated Health Concepts Inc., San Luis Obispo, CA. 483 Issued 07/23/2021

Integrated Health Concepts Inc., San Luis Obispo, CA. 483 Issued 07/23/2021

2 days ago
Remarks by Acting Commissioner Woodcock to the 2021 NORD Breakthrough Summit - 10/19/2021

Remarks by Acting Commissioner Woodcock to the 2021 NORD Breakthrough Summit - 10/19/2021

2 days ago
Merck Issues Voluntary Nationwide Recall of CUBICIN® (Daptomycin for Injection) 500 mg, Lot 934778, Due to Presence of Particulate Matter Identified as Glass Particles

Merck Issues Voluntary Nationwide Recall of CUBICIN® (Daptomycin for Injection) 500 mg, Lot 934778, Due to Presence of Particulate Matter Identified as Glass Particles

2 days ago
FDA issues refuse-to-file letter for application for Barth syndrome

FDA issues refuse-to-file letter for application for Barth syndrome

2 days ago
Federal Judge Enters Consent Decree with Utah-based Dietary Supplement Manufacturer

Federal Judge Enters Consent Decree with Utah-based Dietary Supplement Manufacturer

2 days ago
Statements by Officials of the U.S. Department of Health and Human Services Commemorating the First Openly Transgender Four-Star Officer and First Female Four-Star Admiral of the U.S. Public Health Service Commissioned Corps on October 19, 2021

Statements by Officials of the U.S. Department of Health and Human Services Commemorating the First Openly Transgender Four-Star Officer and First Female Four-Star Admiral of the U.S. Public Health Service Commissioned Corps on October 19, 2021

3 days ago
Biden-Harris Administration Increases HealthCare.Gov Call Center Pay Rate to $15/Hr

Biden-Harris Administration Increases HealthCare.Gov Call Center Pay Rate to $15/Hr

1 week ago
Medicare Open Enrollment Period Kicks Off Today

Medicare Open Enrollment Period Kicks Off Today

1 week ago
HHS Announces Availability of $100 Million for State Loan Repayment Programs to Support Primary Health Care Workforce in Underserved Communities

HHS Announces Availability of $100 Million for State Loan Repayment Programs to Support Primary Health Care Workforce in Underserved Communities

1 week ago
FDA Awards 11 Grants to Clinical Trials to Develop New Medical Products for Rare Disease Treatments

FDA Awards 11 Grants to Clinical Trials to Develop New Medical Products for Rare Disease Treatments

1 week ago
Public Calendar: September 26 - October 2, 2021

Public Calendar: September 26 - October 2, 2021

1 week ago
Abbott Molecular, Inc. Recalls Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kit for Potential False Positive SARS-CoV-2 Test Results

Abbott Molecular, Inc. Recalls Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kit for Potential False Positive SARS-CoV-2 Test Results

1 week ago
FDA to Hold Advisory Committee Meeting to Discuss Merck and Ridgeback’s EUA Application for COVID-19 Oral Treatment

FDA to Hold Advisory Committee Meeting to Discuss Merck and Ridgeback’s EUA Application for COVID-19 Oral Treatment

1 week ago
Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of All Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets Due to Potential Presence of N-nitrosoirbesartan Impurity

Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of All Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets Due to Potential Presence of N-nitrosoirbesartan Impurity

1 week ago
How CDRH’s Digital Transformation Initiative Will Strengthen the Premarket Review Program

How CDRH’s Digital Transformation Initiative Will Strengthen the Premarket Review Program

1 week ago
Declaraciones del Secretario de Salud y Servicios Humanos Xavier Becerra sobre la guía para la reducción de sodio de la FDA

Declaraciones del Secretario de Salud y Servicios Humanos Xavier Becerra sobre la guía para la reducción de sodio de la FDA

1 week ago
Florida Man Pleads Guilty to Payment Processing Fraud Conspiracy

Florida Man Pleads Guilty to Payment Processing Fraud Conspiracy

1 week ago
FDA D.I.S.C.O. Burst Edition: FDA approval of Tecartus (brexucabtagene autoleucel) for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia

FDA D.I.S.C.O. Burst Edition: FDA approval of Tecartus (brexucabtagene autoleucel) for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia

1 week ago
Statement by HHS Xavier Becerra on FDA Sodium Reduction Guidance

Statement by HHS Xavier Becerra on FDA Sodium Reduction Guidance

1 week ago
Readout of the Seventh COVID-19 Health Equity Task Force Meeting

Readout of the Seventh COVID-19 Health Equity Task Force Meeting

1 week ago
Biden-Harris Administration Greenlights Coverage of LGBTQ+ Care as an Essential Health Benefit in Colorado

Biden-Harris Administration Greenlights Coverage of LGBTQ+ Care as an Essential Health Benefit in Colorado

1 week ago
Fact Sheet: Efforts Across HHS to Promote Behavioral Health for Children and Youth

Fact Sheet: Efforts Across HHS to Promote Behavioral Health for Children and Youth

2 weeks ago
HHS Launches Spanish Language App to Help Latinos Navigate Health Care Questions, Issues New Report Highlighting Latino Coverage Issues

HHS Launches Spanish Language App to Help Latinos Navigate Health Care Questions, Issues New Report Highlighting Latino Coverage Issues

2 weeks ago
HHS lanza una aplicación en español para ayudar a los latinos a resolver sus dudas sobre el cuidado de la salud, y publica un nuevo informe que destaca los problemas de cobertura de los latinos

HHS lanza una aplicación en español para ayudar a los latinos a resolver sus dudas sobre el cuidado de la salud, y publica un nuevo informe que destaca los problemas de cobertura de los latinos

2 weeks ago
Statement by HHS Secretary Xavier Becerra on the Swearing-In of Melanie Anne Egorin as Assistant Secretary for Legislation

Statement by HHS Secretary Xavier Becerra on the Swearing-In of Melanie Anne Egorin as Assistant Secretary for Legislation

2 weeks ago
HHS Unveils Climate Adaptation and Resilience Plan and Policy Statement

HHS Unveils Climate Adaptation and Resilience Plan and Policy Statement

2 weeks ago
FDA Drug Topics: How FDA and ISMP Utilize Medication Error Reports to Improve Drug Safety – October 19, 2021

FDA Drug Topics: How FDA and ISMP Utilize Medication Error Reports to Improve Drug Safety – October 19, 2021

2 weeks ago
Remarks by Acting Commissioner Woodcock at the Global Summit on Regulatory Science Research - 10/05/2021

Remarks by Acting Commissioner Woodcock at the Global Summit on Regulatory Science Research - 10/05/2021

2 weeks ago
Imperative Care Inc. Recalls ZOOM 71 Reperfusion Catheter Due to Risk of Breaks During Use

Imperative Care Inc. Recalls ZOOM 71 Reperfusion Catheter Due to Risk of Breaks During Use

2 weeks ago
S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals

S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals

2 weeks ago
FDA Revises Hospital and Health System Compounding Guidance to Help Preserve Patient Access to Compounded Drugs

FDA Revises Hospital and Health System Compounding Guidance to Help Preserve Patient Access to Compounded Drugs

2 weeks ago
MOU-225-21-020 with FDA HAFW1 and WDATCP

MOU-225-21-020 with FDA HAFW1 and WDATCP

2 weeks ago
DeRoyal Industries, Inc. Recalls Procedure Packs Containing Smiths Medical NORMOFLO Irrigation Warming Set Due to the Possibility of Harmful Levels of Aluminum Leaching into the Fluid Path of the Warmers

DeRoyal Industries, Inc. Recalls Procedure Packs Containing Smiths Medical NORMOFLO Irrigation Warming Set Due to the Possibility of Harmful Levels of Aluminum Leaching into the Fluid Path of the Warmers

2 weeks ago
FDA Assesses Impact of Whole Genome Sequencing Program

FDA Assesses Impact of Whole Genome Sequencing Program

2 weeks ago
Baycare Integrated Service Center, Temple Terrace, FL. 483 issued 12/10/2019

Baycare Integrated Service Center, Temple Terrace, FL. 483 issued 12/10/2019

2 weeks ago
HHS Awards $2.21 Billion in Fiscal Year 2021 to Help Americans Access HIV Care, Support Services, and Medication

HHS Awards $2.21 Billion in Fiscal Year 2021 to Help Americans Access HIV Care, Support Services, and Medication

2 weeks ago
U.S. Attorney's Office and HHS Office for Civil Rights Settle Disability Discrimination Case with Backus Hospital

U.S. Attorney's Office and HHS Office for Civil Rights Settle Disability Discrimination Case with Backus Hospital

2 weeks ago
New HHS Report: Vaccination Linked to a Reduction of Over a Quarter Million COVID-19 Cases, 100,000 Hospitalizations, and 39,000 Deaths Among Seniors

New HHS Report: Vaccination Linked to a Reduction of Over a Quarter Million COVID-19 Cases, 100,000 Hospitalizations, and 39,000 Deaths Among Seniors

2 weeks ago
Francis Collins to step down as director of the National Institutes of Health

Francis Collins to step down as director of the National Institutes of Health

2 weeks ago
HHS Issues Final Regulation Aimed at Ensuring Access to Equitable, Affordable, Client-Centered, Quality Family Planning Services

HHS Issues Final Regulation Aimed at Ensuring Access to Equitable, Affordable, Client-Centered, Quality Family Planning Services

2 weeks ago
Vaccines and Related Biological Products Advisory Committee October 26, 2021 Meeting Announcement - 10/26/2021 - 10/26/2021

Vaccines and Related Biological Products Advisory Committee October 26, 2021 Meeting Announcement - 10/26/2021 - 10/26/2021

2 weeks ago
Kentucky, Maine, and New Mexico Launch State Marketplaces for 2022 Coverage

Kentucky, Maine, and New Mexico Launch State Marketplaces for 2022 Coverage

2 weeks ago
Staff Fellow Vacancy Announcement: Chemist and Microbiologist

Staff Fellow Vacancy Announcement: Chemist and Microbiologist

2 weeks ago
FDA Finalizes Two Foundational Rules for Companies Seeking to Market New Tobacco Products

FDA Finalizes Two Foundational Rules for Companies Seeking to Market New Tobacco Products

2 weeks ago
Professional World Store - 612406 - 09/27/2021

Professional World Store - 612406 - 09/27/2021

2 weeks ago

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