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USFDA Guidance: Providing Regulatory Submissions in Electronic Format Using eCTD Specifications

This Friday (13 Septmeber, 2024) the USFDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research...

Sharan Murugan

Sep 15, 20242 min read

USFDA Guidance: Amendments to Abbreviated New Drug Applications (ANDAs) Under GDUFA

FDA's Center for Drug Evaluation and Research revised the final guidance last week titled " ANDA Submissions | Amendments to Abbreviated...

Sharan Murugan

Sep 15, 20242 min read

USFDA Guidance: Appeal Options for Mammography Facilities

The USFDA (U.S. Food and Drug Administration) Center for Devices and Radiological Health provides detailed final guidance " Appeal...

Sharan Murugan

Sep 15, 20242 min read

USFDA Guidance: Incorporating Voluntary Patient Preference Information Over the Total Product Life Cycle

USFDA's Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) released a draft...

Sharan Murugan

Sep 6, 20242 min read

USFDA Guidance: Control of Nitrosamine Impurities in Human Drugs

Earlier today (04 September, 2024) U.S. Food and Drug Administration's Center for Drug Evaluation and Research released the second...

Sharan Murugan

Sep 4, 20242 min read

USFDA Guidance: Bioresearch Monitoring Technical Conformance Guide

The USFDA Center for Drug Evaluation and Research issued the final guidance today (03 September 2024) " Bioresearch Monitoring...

Sharan Murugan

Sep 3, 20242 min read

USFDA Guidance: Electronic Submissions for De Novo Requests and Section 513(g) Requests for Information

Yesterday the U.S. Food and Drug Administration (FDA) has released critical guidance documents to streamline the regulatory pathways for...

Sharan Murugan

Aug 24, 20242 min read

USFDA Guidance: Predetermined Change Control Plans for Medical Devices

The U.S. Food and Drug Administration (FDA) has released a guidance document titled " Predetermined Change Control Plans for Medical...

Sharan Murugan

Aug 24, 20242 min read

USFDA Guidance: Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA

The U.S. Food and Drug Administration (FDA) on August 19, 2024, published the guidance “ Product-Specific Guidance Meetings Between FDA...

Sharan Murugan

Aug 19, 20242 min read

USFDA Guidance: Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases

Last Thursday (08 August 2024) the U.S. Food and Drug Administration (FDA) released final guidance aimed at " Optimizing the Dosage of...

Sharan Murugan

Aug 11, 20242 min read

FDA (ICH) Guidance: M12 Drug Interaction Studies & Questions and Answers

Yesterday (02 August, 2024), the Food and Drug Administration (FDA) announced that the final guidance on M12 drug interactions was...

Sharan Murugan

Aug 3, 20242 min read

USFDA Guidance: User Fee Programs: GDUFA, BSUFA, OMOR, and MDUFA

On July 31, 2024 the U.S. Food and Drug Administration (FDA) recently published in the Federal Register notice (FRN) the User Fee Rates...

Sharan Murugan

Jul 31, 20243 min read

USFDA Guidance: Utilizing Real-World Data in Regulatory Decision-Making for Drug and Biological Products

On July 25, 2024, the U.S. Food and Drug Administration (FDA), through its Center for Drug Evaluation and Research (CDER), Center for...

Sharan Murugan

Jul 27, 20242 min read

USFDA Guidance: Providing Over-the-Counter Monograph Submissions in Electronic Format

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released a final guidance titled "Providing...

Sharan Murugan

Jul 27, 20242 min read

USFDA Guidance: Container Closure System and Component Changes: Glass Vials and Stoppers

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research...

Sharan Murugan

Jul 27, 20242 min read

USFDA Q&A Guidance: Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products

Today (23 July,2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, and Center for Biologics...

Sharan Murugan

Jul 22, 20242 min read

USFDA Guidance: Pediatric IBD Drug Development, Clin.Pharmacology Considerations and BP-Pulse Donor Eligibility Requirements

The US Food and Drug Administration (USFDA) Center for Drug Evaluation and Research recently released updated guidelines "Pediatric...

Sharan Murugan

Jul 20, 20242 min read

USFDA Guidance: Application User Fees for Combination Products

The US Food and Drug Administration published the revised final guidance Application User Fees for Combination Products yesterday (16...

Sharan Murugan

Jul 16, 20242 min read

USFDA MD Guidance: Dental Curing Lights & Composite Resin - Premarket Notification (510(k)) Submissions & Devices Intended to Treat OUD

The US Food and Drug Administration (USFDA) Center for Devices and Radiological Health recently released updated guidelines for dental...

Sharan Murugan

Jul 13, 20242 min read

USFDA Guidance: Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers

The US Food and Drug Administration (FDA) issued a draft guidance for the industry yesterday titled “Addressing Misinformation About...

Sharan Murugan

Jul 9, 20242 min read