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USFDA’s drafts “Benefit-Risk Assessment for New Drug and Biological Products” Guidance
The intent of this guidance is to clarify for drug sponsors and other stakeholders how considerations about a drug’s benefits, risks, and...
Sharan Murugan
Oct 3, 20211 min read
FDA’s finalized “Interpreting Sameness” Gene Therapy Products Guidance
USFDA on 29 September 2021, finalized "Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations". This guidance...
Sharan Murugan
Oct 3, 20211 min read
USFDA’s Q&A Quality (CMC) Related Controlled Correspondence for Generic Drugs
On 20.09.2021, USFDA released an updated Questions and Answers on Quality-Related Controlled Correspondence Guidance for Industry. This...
Sharan Murugan
Sep 23, 20211 min read
USFDA finalizes Q&As on Biosimilar Development
US Food and Drug Administration on 17th September, 2021 finalized additional questions and answers related to biosimilar development and...
Sharan Murugan
Sep 23, 20211 min read
USFDA’s Study Data Technical Conformance Guide & Technical Specifications Doc Update -USA
Study Data Technical Conformance Guide provides specifications, recommendations, and general considerations on how to submit standardized...
Sharan Murugan
Sep 14, 20212 min read
USFDA's updated guidance on Development of ANDA During the COVID-19 Pandemic – Q&A -USA
On 8th September 2021, FDA issued this guidance to provide general recommendations to prospective applicants and applicants of...
Sharan Murugan
Sep 11, 20211 min read
Draft MD Guidance on Performance Criteria for Safety and Performance Based Pathway - USFDA
On 30th August 2021, the Center for Devices and Radiological Health released 2 new draft guidance related to Premarket, 510(k). i.e.,...
Sharan Murugan
Aug 30, 20211 min read
Draft Guidance on PK-Based Criteria for Alternative Dosing Regimens for Treatment of Cancer - USFDA
On 25th August 2021, the Oncology Center of Excellence along with the Center for Drug Evaluation and Research released new draft guidance...
Sharan Murugan
Aug 30, 20211 min read
FDA Export Certification - Revised Guidance -US FDA
This guidance document is intended to provide a general description of FDA Export Certification to industry and foreign governments. This...
Sharan Murugan
Aug 21, 20211 min read
Revised Draft Guidance on Bioequivalence Studies for Generic Drugs – US FDA
On August 20, 2021, FDA Center for Drug Evaluation and Research (CDER) published a revision to the draft guidance for industry...
Sharan Murugan
Aug 21, 20211 min read
FY2022 User Fee Table -USFDA
The User Fee programs help the Food and Drug Administration (FDA) to fulfill its mission of protecting public health and accelerating...
Sharan Murugan
Aug 13, 20212 min read
Request for Comments on pre-Hatch-Waxman ‘PANDA’ applications - FDA
On 12th August, 2021 the US Food and Drug Administration (FDA) announced the establishment of a public docket to solicit comments on...
Sharan Murugan
Aug 13, 20211 min read
Guidance on Development and Submission of Near Infrared Analytical Procedures– USFDA
US Food and Drug Administration (FDA) on 06-July-2021, finalized guidance on “Development and Submission of Near Infrared Analytical...
Sharan Murugan
Aug 8, 20211 min read
Guidance on Metastasis-Free Survival as an Endpoint - Prostate Cancer trials – USFDA
USFDA on 06-July-2021, finalized guidance on the use of metastasis-free survival (MFS) as an endpoint in clinical trials for...
Sharan Murugan
Aug 8, 20211 min read
Final Guidance - FAR Submission: Q&A – US FDA
FDA announced the availability of a final guidance for the industry entitled "Field Alert Report (FAR) Submission: Questions and...
Sharan Murugan
Jul 25, 20211 min read
Final Guidance on Unique Device Identification System: Form and Content of the UDI – US FDA
The US Food and Drug Administration (FDA) yesterday (06-July-2021) finalized its guidance on the form and content requirements for unique...
Sharan Murugan
Jul 7, 20211 min read
Draft guidance for Transdermal Adhesion Systems– US FDA
This guidance provides recommendations for clinical trials designed to assess the adhesion performance of transdermal and topical...
Sharan Murugan
Jul 5, 20211 min read
Providing Regulatory Submissions in Alternate Electronic Format – US FDA
The US Food and Drug Administration on 1st-July,2021 issued final guidance to assist sponsors in using alternate electronic formats for...
Sharan Murugan
Jul 5, 20211 min read
Guidance on CMC Changes to an Approved Application- US-FDA
FDA issued final guidance on June 21, 2021 to aid applicants of certain licensed biological products to determine the appropriate...
Sharan Murugan
Jun 27, 20211 min read
Guidance on Providing Regulatory Submission in e-Format for Standardized Study Data -US FDA
This guidance and the technical specifications document it incorporates by reference describe the requirements for electronic submission...
Sharan Murugan
Jun 27, 20211 min read