An Overview of Drug Master Files

Albert Yehaskel, Independent Advisor for Pharmaceutical Submissions

20180118

DMFs are regulatory submissions to FDA for drug substances, drug products, and/or container closures allowing FDA to review information such as confidential details about facilities, processes, components, or articles used in the manufacturing, processing, packaging, and storing of one or more APIs and/or human drugs. DMFs are at the discretion of the DMF holder and provided in the absence of relevant information in the CMC section of an application. These submissions support a third party’s application without revealing the information to the third party and maintain the confidentiality of proprietary information (e.g., a synthetic or manufacturing procedure) for the holder, allowing review of information by reviewers at FDA to support applications. The information contained in a DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA/BLA), an Abbreviated New Drug Application (ANDA), another DMF, an Export Application, and any amendments and supplements to any of these applications.

The Role of Regulatory Affairs in Product Development

Neil Smith and Sandy Brand, Independent Consultants, EAS Consulting Group, LLC

20171102

Regulatory Affairs touches each and every product within a company, ensuring compliance with local regulations and internal policies and the creation of sound guidelines related to labeling, safety, and nutrition. Through the strategic links to trade associations, Government agencies, and NGO’s the business is kept abreast of all changes in regulations that may affect the business, as well as key developments in science, based upon which regulatory affairs professionals provide direction on the product development process so that the business achieves the best outcome.

Proactive Regulatory Affairs professionals should provide strategic and technical advice to all levels of the business and at all stages of the product cycle, from ideation or concept discussions through to commercialization, and beyond. Conversely, proactive engagement with Regulatory Affairs by all levels within the business ensures decision making that is consistent, timely, and accounts for all factors.

Getting Your Medical Device Into the US Market

Joe Ouellette, Independent Consultant EAS Consulting Group, LLC

20170926

The White Paper provides real-world and practical information directed to the manufacturer of Class II and Class III devices in navigating the Premarket Notification 510(k) clearance with insight into the various documentation required by FDA for submitting a 501(k). Getting a device ready for 510(k) submission is can be time-consuming, costly, full of challenges and EAS Independent Consultant Joseph Ouellette lays out the various requirements and suggestions for completing the forms in an expeditious and accurate manner. He also discusses some practical tips such as the development of a regulatory plan with a list of deliverables as well as anticipating questions FDA may ask throughout the process in order to successfully navigate the application process.

Compliance With EU Food Regulation: What if Traceability and Food Recall are Not Enough?

Prepared by EAS Consulting Group Affiliates from Almater Food Technologists srl and Lexma Consulting, Italy

20180823

EAS Consulting Group, LLC, leaders in FDA regulatory consulting is pleased to release a joint White Paper prepared by Italian business associate, Almater Food Technologists and Consultants srl (Italy) and LEXMA, who provide consulting services to food firms wish to comply with EU directives and/or individual European country food laws as well as for European firms intending to export food products for human and animal consumption into the US marketplace. Almater/LEXMA are independent consultants under contract to EAS. Their combined resources are now available through EAS Consulting Group. The White Paper, titled “Compliance with EU Food Regulation: What if Traceability and Food Recall Are Not Enough?” discusses the extent to which the EU regulatory framework on food may impact and challenge the traditional operations of food manufacturers, particularly once a crisis erupts as well as how integration of legal, regulatory and technical expertise may improve the efficacy of a food manufacturer’s crisis management plan. Case studies are included as illustrations of how traditional operational methods resulted in aggressive responses by either EU or individual European country authorities Together EAS,

The White Paper, titled “Compliance with EU Food Regulation: What if Traceability and Food Recall Are Not Enough?” discusses the extent to which the EU regulatory framework on food may impact and challenge the traditional operations of food manufacturers, particularly once a crisis erupts as well as how integration of legal, regulatory and technical expertise may improve the efficacy of a food manufacturer’s crisis management plan. Case studies are included as illustrations of how traditional operational methods resulted in aggressive responses by either EU or individual European country authoritiesTogether EAS,

Together EAS, Almater, and LEXMA provide highly technical regulatory consulting assistance with expertise in both European and US food safety laws, regulations and their enforcement by the respective government authorities. The use if this expertise will better enable firms to meet the new and changing European and American requirements for food processors, particularly those that are “foreign suppliers” from a US perspective and are required to comply with FDA’s Food Safety Modernization Act (FSMA). EAS provides technical assistance to US-based food processors and importers in becoming compliant with the FSMA Preventive Controls and FSVP while Almater and LEXMA provide assistance from the perspective of a European food processor intending to keep its US market open and available.

Analysis of Final FDA Regulations Establishing New Reference Amounts Customarily Consumed (RACCs), New Requirements for Single Serving Containers, and Dual Column Labeling

Bruce Silverglade, Independent Consultant, EAS Consulting Group, LLC

20160825

Disclosures on the Nutrition Facts label are based on serving sizes derived from Reference Amounts Customarily Consumed ("RACCs") that are determined by FDA. FDA has changed its RACCs for dozens of food categories, affecting the number of nutrients for customary servings of foods that companies must list on the Nutrition Facts label. FDA has also changed its regulations on single-serving packages, again affecting the number of nutrients that will need be disclosed on the label. Thus, FDA's new regulations have a direct impact on the amount of fat, sodium, and sugars that companies must disclose on the Nutrition Facts Label. Some foods may appear higher in these nutrients than before the new regulations. This paper analyzes the changes and discusses implications for food companies.

FDA’s Design Control Requirements for Medical Devices

Prepared by Kaiser J Aziz, Ph.D., Independent Consultant, EAS Consulting Group, LLC

20160725

FDA reviews, evaluates, verifies and validates the implementation of the design control requirements described in the device premarket applications (510k/ PMA). Design control requirements play a key role from the device design prototype, the manufacturing process to the finished device for user needs. Design controls are an integrated set of management practices and procedures which are applied to control design activities while assessing and maintaining device quality throughout the total product life cycle (TPLC).

Analysis of Final FDA Regulations Amending the Nutrition Facts Label – Focus on Added Sugars

Bruce Silverglade, Independent Consultant, EAS Consulting Group, LLC

20160622

This White Paper provides an analysis of FDA’s final regulation amending the Nutrition Facts label, focusing on FDA’s new requirement for added sugars content disclosure and disclosing a %DV for added sugars. The impacts of other provisions of the final rule related to the new added sugars disclosure are discussed as well. In addition, FDA’s new record-keeping requirements for added sugars are reviewed. An annotated table of contents to the final rule is attached as an appendix.