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Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products

Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products

Docket Number: FDA-2017-D-6159 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research, Office of Therapeutic Products The purpose of this guidance is to discuss methods and approaches for capturing postapproval safety and...

Owner:  American Government
Expedited Programs for Regenerative Medicine Therapies for Serious Conditions

Expedited Programs for Regenerative Medicine Therapies for Serious Conditions

Docket Number: FDA-2017-D-6159 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research, Office of Therapeutic Products This guidance provides sponsors engaged in the development of regenerative medicine therapies for...

Owner:  American Government
Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations

Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations

Docket Number: FDA-2025-D-3403 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research, Office of Therapeutic Products This guidance provides recommendations to sponsors who are planning clinical trials of cell and gene...

Owner:  American Government
Heinrich, N.M. Delegation Demand Trump Administration Omit New Mexico from Roadless Rule Rescission

Heinrich, N.M. Delegation Demand Trump Administration Omit New Mexico from Roadless Rule Rescission

Lawmakers to Rollins: “We are concerned that rolling back this rule would hurt our state’s economy, diminish its wildlife, and endanger its residents” WASHINGTON — U.S. Senators Martin Heinrich (D-N.M.), Ranking Member of the U.S. Senate Energy...

Owner:  American Government
Redodo October Prime Day Early Sale: Up to 55% Off LiFePO4 Batteries
Dried Food Market Size to Exceed USD 15.66 Billion by 2034 | Towards FnB
The Pickled Beet Welcomes a New ​​Client Services Specialist
AAFA and MICM Lead Trade Mission to the Dominican Republic to Strengthen Regional Supply Chains
Erosive Esophagitis: Developing Drugs for Treatment

Erosive Esophagitis: Developing Drugs for Treatment

Docket Number: FDA-2025-D-0346 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “Erosive...

Owner:  American Government
Disseminated Coccidioidomycosis: Developing Drugs for Treatment

Disseminated Coccidioidomycosis: Developing Drugs for Treatment

Docket Number: FDA-2025-D-1308 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Disseminated...

Owner:  American Government
Symptomatic Nonerosive Gastroesophageal Reflux Disease:  Developing Drugs for Treatment

Symptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for Treatment

Docket Number: FDA-2025-D-0331 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “Symptomatic...

Owner:  American Government
General Principles of Software Validation

General Principles of Software Validation

Docket Number: FDA-1997-D-0029 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Devices and Radiological Health This guidance outlines general validation principles that the Food and Drug Administration...

Owner:  American Government
Bacteriocins & Protective Cultures Market to Reach USD 803.13M by 2032 | Driven by RTE Foods & Natural Preservatives
PER® and Urology Times® to host fourth annual Urology on the Beach event with University of Miami Health System’s Desai Sethi Urology Institute
Global Companion Diagnostics Market to Surpass USD 13.6 Billion by 2029 | MarketsandMarkets™
CNS (Central Nervous System Biomarkers) Market Revenue to Hit US$11.00Bn by 2033
Air Quality Sensor Market Size, Share & Trends Analysis Report By Product
Docks Market 2025-2029: Unveiling Growth Developments with the Latest Updates
CAGR of 5.7% | Cycloalkanes Market Size: Key Trends and Growth Insights, 2031
Over $575K in Funding to Support Local Food and Agriculture Announced at RI Grown Week Kickoff

Over $575K in Funding to Support Local Food and Agriculture Announced at RI Grown Week Kickoff

Published on Monday, October 06, 2025 PROVIDENCE, RI – Today the Rhode Island Department of Environmental Management (DEM) announced over $575K in program funding to support local food and agriculture at Farm Fresh Rhode Island (FFRI) in...

Owner:  American Government

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