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

6 days ago
2 min

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...

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USFDA Guidance: Control of Nitrosamine Impurities in Human Drugs

Sharan Murugan

Sep 4
2 min

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...

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USFDA Guidance: Bioresearch Monitoring Technical Conformance Guide

Sharan Murugan

Sep 3
2 min

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...

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

Sharan Murugan

Aug 24
2 min

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...

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USFDA Guidance: Predetermined Change Control Plans for Medical Devices

Sharan Murugan

Aug 24
2 min

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...

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

Sharan Murugan

Aug 19
2 min

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...

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

Sharan Murugan

Aug 11
2 min

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...

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

Sharan Murugan

Aug 3
2 min

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...

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

Sharan Murugan

Jul 31
3 min

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...

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

Sharan Murugan

Jul 27
2 min

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...

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

Sharan Murugan

Jul 27
2 min

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...

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

Sharan Murugan

Jul 27
2 min

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...

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

Sharan Murugan

Jul 22
2 min

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...

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

Sharan Murugan

Jul 20
2 min

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...

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USFDA Guidance: Application User Fees for Combination Products

Sharan Murugan

Jul 16
2 min

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...

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

Sharan Murugan

Jul 13
2 min

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...

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

Sharan Murugan

Jul 9
2 min

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...

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USFDA Guidance: Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products

Sharan Murugan

Jul 8
2 min

USFDA Guidance: Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products

Today (08 July, 2024) the US Food and Drug Administration (FDA) has released guidance "Purpose and Content of Use-Related Risk Analyses...

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USFDA: Guidance on Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products

Sharan Murugan

Jun 29
2 min

USFDA: Guidance on Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products

The U.S. Food and Drug Administration, yesterday announced the release of a draft guidance, Essential Drug Delivery Outputs for Devices...

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USFDA Guidance: Interchangeability: Considerations in Demonstrating Interchangeability With a Reference Product

Sharan Murugan

Jun 22
2 min

USFDA Guidance: Interchangeability: Considerations in Demonstrating Interchangeability With a Reference Product

The USFDA's updated guidance (21 June, 2024) on "Considerations in Demonstrating Interchangeability With a Reference Product" provides...

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