The US Food and Drug Administration (FDA) on Friday released draft guidance describing how FDA plans to implement the requirements for the electronic submission of Risk Evaluation and Mitigation Strategies (REMS) documents in certain submissions under new drug applications, abbreviated new drug applications and biologics license applications. The agency said the implementation will begin no earlier than 24 months after issuance of the final guidance. The 7-page dr...

The US Food and Drug Administration (FDA) on Monday said it is drafting and seeking comment on the use of standardized Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC) data elements for electronic submission. FDA, which is considering implementing PQ/CMC requirements as a Health Level 7 (HL7) Structured Product Labeling (SPL) document, said the move to standardize PQ/CMC data elements and terminologies will improve the efficiency and quality of th...

Beginning 5 May, pharmaceutical, biologic and generic manufacturers will have to submit to the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) all New Drug Applications (NDAs), Biologics License Application (BLAs) and Abbreviated New Drug Applications (ANDAs) using the electronic Common Technical Document (eCTD). Drug Master Files (DMFs), Biological Product Files (BPFs)...

The US Food and Drug Administration (FDA) on Friday issued new draft guidance updating the agency’s current thinking on a program used to accredit third parties to review premarket notification (510(k)) submissions for medical devices and recommend the initial classification of certain devices. In an effort to encourage harmonization, the guidance refers to standards described in the International Medical Device Regulators Forum (IMDRF) documents as criteria FDA will con...

This article discusses how an integrated, six-point electronic Common Technical Document (eCTD) publishing strategy can accelerate global submissions and enhance the efficiency of regulatory operations. In addition, it outlines challenges specific to: large companies with a well-established, eCTD-compliant publishing capacity, but may lack strategic agility; and smaller companies with limited eCTD resources and expertise. The World - and Sponsor Challenges - are Gettin...

For life sciences companies, paper-based commercial material submissions do not cut it anymore, not only when it comes to automating processes for improved efficiency, but also in the face of rapidly approaching new regulatory guidelines on electronic submissions from FDA. This article discusses the urgency as well as the findings of a 2015 global commercial content management study. Each year, life sciences companies send more than 80,000 promotional material submissi...

At the second meeting focused on the fourth iteration of the Medical Device User Fee Agreements (MDUFA) for 2017, both the US Food and Drug Administration (FDA) and industry reiterated agreement that the program overall has improved and is heading in a positive direction. The negotiations center on the use of a system whereby medical device companies pay fees to FDA to register their establishments and list their devices with the agency. The fees help FDA increase the ef...

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) announced it has completed a step in the development of the next major version of the electronic Common Technical Document (eCTD). ICH’s M8 expert working group (EWG) has completed a draft of the implementation guide for ICH eCTD v4.0, the first major version change since v3.0 was adopted in 2003. Background ICH was formed followin...

Preparing regulatory documents for electronic submission (known as publishing) can be time consuming and complicated, whether the project is a small submission, such as a meeting request, or a new marketing application, and regardless of how well the content is written. Improper formatting can complicate the electronic submission preparation process further. Such documents require additional time and resources for publishing and potentially can result in costly subm...

Northern Africa is an emerging region that presents a unique and diverse set of regulatory considerations . Through the World Health Organization (WHO), US Food and Drug Administration (FDA) and European Medicines Agency (EMA), sponsors have been able to leverage the regulatory review and approval of medicines in International Conference on Harmonization (ICH) countries to access drugs to treat major diseases. While some of these regulatory pathways, including the...

The US Food and Drug Administration's (FDA) device and biologics review divisions have made several small enhancements and fixes to the eSubmitter system, the agency's electronic system for receiving, filing and tracking product submissions. The eSubmitter system is currently used by the Center for Biologics Evaluation and Research (CBER) and the Center for Devices and Radiological Health (CDRH), as well as FDA's veterinary and tobacco divisions. Both CDRH an...

Two of the pharmaceutical industry's largest trade groups are weighing in on the US Food and Drug Administration's (FDA) proposal to digitize the drug application submission process, saying the agency is generally on-point, but needs to clarify a few outstanding issues. Background In 2012, the  Food and Drug Administration Safety and Innovation Act ( FDASIA ) was passed into law, and with it a provision mandating that all applications submitted under Section 5...