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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: 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
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...
Sharan Murugan
Jul 8, 20242 min read
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...
Sharan Murugan
Jun 29, 20242 min read
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...
Sharan Murugan
Jun 22, 20242 min read
USFDA Guidance: Facility Readiness: Goal Date Decisions Under GDUFA
The US FDA has released final guidance for industry applicants "Facility Readiness: Goal Date Decisions Under GDUFA" which helps assign...
Sharan Murugan
Jun 20, 20242 min read
USFDA Guidance: Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics
The US Food and Drug Administration (FDA) released the final guidance yesterday (14 June 2024) titled "Clinical Pharmacology...
Sharan Murugan
Jun 15, 20242 min read
USFDA Guidance: BIMO Inspections Processes, Practices & Standardized Format for Electronic Submission
The US Food and Drug Administration (USFDA) is announcing the availability of a draft guidance for the industry entitled “Processes and...
Sharan Murugan
Jun 9, 20242 min read
USFDA Guidance: Platform Technology Designation Program for Drug Development
Today (29 May 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics...
Sharan Murugan
May 28, 20242 min read
USFDA Med Dev: Guidance on Remanufacturing of Medical Devices
Recently (09 May, 2024) the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released the...
Sharan Murugan
May 11, 20241 min read
USFDA Guidance: REMS Logic Model: A Framework to Link Program Design With Assessment
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research...
Sharan Murugan
May 11, 20242 min read