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USFDA Guidance: Six Finalized Medical Devices Guidelines
USFDA finalized and released Multiple Medical Devices Guideline earlier today (28 September 2022). 1. Guidance on: Clinical Performance...
Sharan Murugan
Sep 28, 20222 min read
USFDA Guidance: Clinical Investigations of Medical Products Involving Children
A draft guidance was released on 23 September 2022 by the US Food and Drug Administration on the ethical considerations for including and...
Sharan Murugan
Sep 25, 20221 min read
USFDA Guidance: Electronic Submission Template for Medical Device 510(k) Submissions
This document was issued on September 22, 2022. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be...
Sharan Murugan
Sep 23, 20221 min read
USFDA Guidance: Distribution of Approved Naloxone Products -Immediately-in-Effect
Yesterday (22 September 2022) USFDA issued “Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act...
Sharan Murugan
Sep 23, 20221 min read
USFDA Guide: Updated eCTD 4.0 - TECHNICAL CONFORMANCE GUIDE,
Recently USFDA released an updated "Electronic Common Technical Document (eCTD) Technical Conformance Guide" that revised some sections...
Sharan Murugan
Sep 17, 20221 min read
USFDA: Annual Summary Reporting Requirements -Right to Try Act -Final Rule
In yesterday's final rule, the U.S. Food and Drug Administration outlined (Unpublished version) the requirements for annual reports by...
Sharan Murugan
Sep 14, 20221 min read
USFDA: Office of New Drugs Research Program & Guidance - Software Assurance for Production & Quality
Yesterday (13-September,2022) FDA published a new webpage to share the most recent research activities of the Center for Drug Evaluation...
Sharan Murugan
Sep 14, 20222 min read
USFDA Guidance: Submitting Documents Using Real-World Data & RW Evidence for Drug & Biologics
Earlier today (08-September-2022) USFDA's Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research...
Sharan Murugan
Sep 8, 20221 min read
USFDA Guidance: Content & Format of Labeling for Non-Prescription Drugs, Quantitative Labeling
Earlier today on 8-September-2022, USFDA's Center for Drug Evaluation and Research, Office of New Drugs published two draft Labeling...
Sharan Murugan
Sep 8, 20222 min read
USFDA Guidance: Clinical Pharmacology Considerations for Pediatric Studies of Drugs & Biologics
Yesterday 07-September-2022, USFDA's Center for Drug Evaluation and Research published a draft guideline "General Clinical Pharmacology...
Sharan Murugan
Sep 8, 20221 min read
USFDA Guidance: Charging for Investigational Drugs Under an IND: Questions and Answers
This draft guidance is released today for Public comments and when finalized, this guidance will replace Charging for Investigational...
Sharan Murugan
Aug 22, 20221 min read
USFDA's Guidance on Hearing Aid Devices, Replacement Reagent & Contact Lens Care Products
Today USFDA's Center for Devices and Radiological Health updated multiple guidances such as "Regulatory Requirements for Hearing Aid...
Sharan Murugan
Aug 17, 20222 min read
USFDA's New WebPage: For Complex Generics
Friday the USFDA agency published a new web page to share the most recent FDA actions and activities related to complex generics, which...
Sharan Murugan
Aug 7, 20221 min read
USFDA Guidance: Electronic Submission of Expedited Safety Reports From IND- Exempt BA/BE Studies
Today (August 2, 2022) FDA published draft guidance for the industry, “Electronic Submission of Expedited Safety Reports from IND-Exempt...
Sharan Murugan
Aug 2, 20221 min read
USFDA Guidance: Changes to Disposable Manufacturing Materials, Clinical Pharmacology Considerations
Multiple guidances were updated and released by the USFDA last week and had some important updates related to Drugs, Biologics, and...
Sharan Murugan
Jul 31, 20222 min read
USFDA: Revising the National Drug Code Format and Drug Label Barcode Requirements
On July 22, 2022, FDA announced the availability of a proposed rule, Revising the National Drug Code Format and Drug Label Barcode...
Sharan Murugan
Jul 24, 20221 min read
USFDA's Guidance: Failure to Respond to an ANDA Complete Response Letter Within the Timeframe
On 22-July 2022, USFDA released multiple guidance among them one is "Failure to Respond to an ANDA Complete Response Letter Within the...
Sharan Murugan
Jul 23, 20222 min read
USFDA's Draft Guidance: Orange Book Questions and Answers
On 22-July 2022, USFDA released multiple guidance among them one is "Orange Book Questions and Answers Guidance for Industry. What is...
Sharan Murugan
Jul 23, 20221 min read
USFDA's Draft Guidance: Conducting Remote Regulatory Assessments Q&A
On 22-July 2022, USFDA released multiple guidance among them one is "Conducting Remote Regulatory Assessments Questions and Answers"....
Sharan Murugan
Jul 23, 20221 min read
USFDA Guidance on Providing Regulatory Submissions in Alternate Electronic Format
This updated guidance provides recommendations on an alternate electronic format for submissions covered under an exemption from or a...
Sharan Murugan
Jun 26, 20221 min read