Part 3 of the “Are You Aloof About OMUFA, MDUFA, and GDUFA?” series. Final installment in a three-part series on FDA user fee programs. Part 1 covered OMUFA, Part 2 covered MDUFA, and this article focuses on GDUFA. GDUFA Is More Than an ANDA Fee...
Part 2 of the “Are You Aloof About OMUFA, MDUFA, and GDUFA?” series. This is the second installment in a three-part series on FDA user fee programs. Part 1 covered OMUFA, and Part 3 will address GDUFA. MDUFA Is More Than Just a Submission Fee ...
Part 1 of the “Are You Aloof About OMUFA, MDUFA, and GDUFA?” series. This is the first installment in a three-part series examining FDA user fee programs affecting OTC drugs, medical devices, and generic drugs. Part 1 covers OMUFA. Part 2 will address...
Drug Master Files, manufacturer listings, and Electronic Common Technical Document (eCTD) submissions are foundational to regulatory compliance. Yet even experienced regulatory, quality, and operations teams can encounter avoidable errors that delay approvals,...
The FDA’s final rule, “Revising the National Drug Code Format and Drug Label Barcode Requirements,” establishes a uniform 12-digit format for FDA-assigned National Drug Codes (NDCs) . This change will standardize how drugs marketed in the U.S...
LexisNexis Life Sciences Solutions and ONIX expand strategic alliance to guide pharma customers to market faster Professionals in the life sciences industry rely on unique regulatory affairs expertise to effectively manage the full end-to-end Electronic Common...
On December 9, 2025, the US Food and Drug Administration (FDA) finalized guidance on promotional labeling and advertising for biologics, biosimilars, and interchangeable biosimilars. The guidance aims to ensure that promotional materials are accurate, truthful...
As of today, U.S. Prescribing Information (USPI) must still be distributed to prescribing healthcare professionals in printed paper format. Despite ongoing discussions around digital transformation and electronic product information, the requirement for printed...
Health Canada continues to make strides in modernizing the way pharmaceutical product information is structured and shared. As part of its digital transformation efforts, the agency is advancing the implementation of the XML Product Monograph (XML-PM) requirement...
The Food and Drug Administration (FDA) requires drug manufacturers to keep their listings updated each year, with most deadlines falling on December 31st. When a manufacturer misses these deadlines, the drug is at risk of becoming inactive. The FDA has sent notices...
The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) introduced reforms to the OTC drug review process. As of October 1, 2024, the listing of OTC monograph drug products requires the use of the current Marketing Category and Application Number values...
Following a lengthy period of anticipation, Health Canada has released Draft Guidance Document Preparation of the Product Monograph in Extensible Markup Language (XML) Format and sample files. Along with the draft guidance, Health Canada has opened a comment period...
FDA releases MoCRA draft guidance on cosmetic facility registration and product listing On August 7, 2023, the Food and Drug Administration (FDA) released draft guidance providing recommendations and instructions pertaining to the collection and submission of...
FDA has updated eCTD guidance to recommend structure-data files In November of 2022, the Food and Drug Administration (FDA) published a new version of the eCTD Technical Conformance Guide , amending it to include a new section. This new section, 3.3.3, focuses...
Health Canada second-language product monograph requirements Effective March 10, 2023, Health Canada changed submission requirements for second-language product monographs for human drugs. This change no longer requires the second language product monograph at...
As of December 28, 2022, all new REMS (Risk Evaluation and Mitigation Strategy) submissions and all REMS updates are required to be submitted in SPL (Structured Product Labeling) format per the FDA. This is in compliance with the Final Guidance on REMS issued by...
Combination products: regulatory requirements and how to comply Combination Products continue to be at the forefront of regulatory chatter. Our customers, both medical device and pharmaceutical, are regularly coming to us with questions surrounding this topic...
FDA drug distribution amounts report: frequently asked questions and more In late 2021, the US Food and Drug Administration (FDA) instituted a new annual distribution report, Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of...
What is a New Drug Application (NDA)? Every new drug in the United States needs to come to market through a New Drug Application with the FDA. According to the FDA, “The NDA application is the vehicle through which drug sponsors formally propose that the...
In China, key regulatory policies originate with the State Council (Executive Branch). At the policy level, regulations for medical devices started in 2016 with a five-year plan. For regulatory compliance, typically there is a registration process, clinical evaluation...