Regulatory Sciences
What to Expect During the NDA Review Process
Compiling and submitting a New Drug Application (NDA) submission is a complicated and intensive activity. Once you have submitted your application to FDA, you may be curious about what can you expect...
Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Guidance for Industry
Guidance Document August 2022 This guidance provides instructions for the electronic submission of expedited individual case safety reports (ICSRs) from investigational new drug (IND)-exempt...
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EMA Good clinical practice (GCP) inspection procedures
The Good Clinical Practice (GCP) Inspectors Working Group has developed procedures for the coordination, preparation, conduct and reporting of GCP inspections requested by the European Medicines...
FDA Issues Final Guidance on Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors
FDA has issued the final guidance titled “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.” The recommendations for prescription drug and...
Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production - Level 2 revision
Guidance for Industry May 2022 Today, FDA is announcing revisions to the 2006 guidance “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.” Specifically, this...
EMA Takes Steps to Minimize Animal Testing During Product Development
On Wednesday, September 29th, EMA announced the implementation of new measures indented to replace, reduce, and refine animal use in the development, manufacturing, and testing of human and...
FDA Announces Update to Nonproprietary Naming Convention for Biosimilar Products
On Thursday, March 7th, FDA published a revised draft guidance, updating its nonproprietary naming convention for biological products licensed under section 351 of the Public Health Service Act (PHS...
FDA Approves Nasal Spray to Treat Depression in Adults
Earlier this month, FDA announced the approval of Spravato (esketamine) nasal spray. The product is to be used in conjunction with an oral antidepressant and is indicated for the treatment of...
FDA Issues Draft Guidance to Advance Development of Combination Products
On Tuesday, February 5th, FDA published a draft guidance explaining the principles for premarket review of combination products, including how to determine which type of premarket submission is...
FDA Draft Guidance on Tentatively Approved ANDA Submissions
On Wednesday, January 16th, the FDA published its first draft guidance since the partial government shutdown took effect on December 22, 2018. The draft guidance, entitled "ANDA Submissions –...
Regulatory Sciences
Human Subject Protection Regulations: Differences Between HHS’ & FDA’s Clinical Trial Rules
On Friday, October 12th, FDA issued a guidance document entitled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.” The document aims to help...
CBER Provides Sponsors with Policies and Procedures Regarding INTERACT Meetings
On Monday, October 1, FDA’s Center for Biologics Evaluation and Research (CBER) issued a document outlining the policies and procedures for scheduling and conducting INitial Targeted Engagement for...
Good Review Management Principles & Practices, Part One: Fundamental Values
On Tuesday, September 25th, the FDA published a draft guidance containing recommendations on good review management principles and practices (GRMPs) for new drug applications (NDAs), Biologics...
FDA Releases Draft Guidance on Benefit-Risk Determinations for Devices
On Thursday, September 6th, the FDA released a new draft guidance regarding benefit-risk determinations in medical device premarket approval applications (PMAs), De Novo requests, and humanitarian...
FDA Prescription Drug User Fee Rates: Fiscal Year 2019
On Wednesday, August 1st, FDA released a notice with updated prescription drug user fee rates for fiscal year 2019. Prescription Drug Application Fees According to the Food, Drug, & Cosmetic (FD&C)...
What Should Be on Your Clinical Trial Investigator Site Audit Checklist?
What Should Be on Your Clinical Trial Investigator Site Audit Checklist?: You live and operate in a regulated industry. Obviously, it’s crucial that you stay in compliance during your clinical...