Search
USFDA MD Guidance: Enforcement Policies for Tests During a Section 564 Declared Emergency & for Certain In Vitro Diagnostic Devices
Today (06 May 2024) the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released two draft guidances...
Sharan Murugan
May 6, 20242 min read
USFDA Guidance: Considerations for the Use of Human-and Animal-Derived Materials & Recognition and Use of a Standard for Uniform Blood & Blood Component Container Labels
Yesterday (30 April 2024), the FDA released a draft guidance for the industry titled "Considerations for the Use of Human-and...
Sharan Murugan
May 1, 20242 min read
USFDA Guidance: Content and Format of Composition Statements in NDAs and ANDAs and Corresponding Statement of Ingredients in Labeling
Today (29 April 2024), FDA released a new draft guidance for the industry titled "Content and Format of Composition Statement and...
Sharan Murugan
Apr 27, 20242 min read
USFDA Guidance: Cancer Clinical Trial Eligibility Criterias
The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence, Center for Drug Evaluation and Research, and Center for...
Sharan Murugan
Apr 27, 20242 min read
USFDA Guidance: Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Q&A
On 24 April 2026 (Wednesday) the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research released a...
Sharan Murugan
Apr 27, 20242 min read
USFDA: Guidance one eSubmission of Expedited Safety Reports From IND-Exempt BA/BE Studies and Data Integrity for In Vivo BA & BE studies
Today (04 April 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released draft guidance on...
Sharan Murugan
Apr 4, 20242 min read
USFDA Guidance: Regional Implementation Guide for E2B (R3) e-Transmission of ICSR and Providing Regulatory Submissions in Electronic Format: IND Safety Reports
Today (01 April 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics...
Sharan Murugan
Mar 30, 20242 min read
USFDA Guidance: Handling and Retention of Bioavailability (BA) & Bioequivalence (BE) Testing Samples
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research updated and released the draft guidance "Handling and...
Sharan Murugan
Mar 27, 20242 min read
USFDA Guidance: Controlled Correspondence Related to Generic Drug Development
On 18th March, 2024 the U.S. Food and Drug Administration (FDA) the Center for Drug Evaluation and Research released the final guidance...
Sharan Murugan
Mar 20, 20242 min read
USFDA Guidance: Annual Reportable Labeling Changes for NDA and ANDA for Nonprescription Drug Products
Today (13 March, 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released the draft guidance...
Sharan Murugan
Mar 13, 20242 min read
USFDA Med.Dev: Draft Guidance Select Updates for the Premarket Cybersecurity -Section 524B of the FD&C Act
Today (13 March, 2024) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research Center for Devices and...
Sharan Murugan
Mar 13, 20241 min read
USFDA Guidance: Clinical Pharmacology Considerations for Antibody-Drug Conjugates
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research...
Sharan Murugan
Mar 5, 20242 min read
USFDA Guidance: Reporting Amount of Listed Drugs and Biological Product and Key Information and Facilitating Understanding in Informed Consent Guidance
Earlier this week (26 & 29 February 2024) the the U.S. Food and Drug Administration (FDA) released two guidances "Reporting Amount of...
Sharan Murugan
Mar 2, 20242 min read
USFDA Guidance: Q&A-Charging for Investigational Drugs Under an IND - What You Need to Know
Earlier this week (14 February, 2024) the the U.S. Food and Drug Administration (FDA) released guidance "Charging for Investigational...
Sharan Murugan
Feb 17, 20241 min read
USFDA Guidance: Use of Data Monitoring Committees in Clinical Trials
Today (13 February 2024) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research, Center for Devices...
Sharan Murugan
Feb 13, 20242 min read
USFDA CMC Guidance: Advanced Manufacturing Technologies Designation Program
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research...
Sharan Murugan
Feb 13, 20242 min read
USFDA Guidance: "Understanding FDA's QMSR Final Rule: What You Need to Know for the Transition Period"
The U.S. Food and Drug Administration (FDA) plays a crucial role in ensuring the safety and effectiveness of medical devices. In pursuit...
Sharan Murugan
Feb 4, 20242 min read
USFDA Guidance: Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products
FDA announced on Monday (29-January-2024) that a draft guidance for the industry is available titled, "Collection of Race and Ethnicity...
Sharan Murugan
Jan 31, 20241 min read
USFDA Guidance: Human Gene Therapy Products Incorporating Human Genome Editing & Development of Chimeric Antigen Receptor (CAR) T Cell Products
On Monday (29 January 2024) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation released two...
Sharan Murugan
Jan 31, 20242 min read
USFDA Guidance: Conducting Remote Regulatory Assessments Questions and Answers
Last Friday (26 January 2024), the FDA Office of Regulatory Affairs announced the availability of a revised draft guidance for the...
Sharan Murugan
Jan 28, 20242 min read