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Both the FDA and Health Canada have issued guidances to industry that require Drug Master Files (DMFs) to be provided in electronic formats by defined deadlines.
Health Canada has required that DMFs be filed in an electronic (non-eCTD) format, at minimum, since April 2016.
FDA (CBER and CDER) will require all new DMFs and amendments to existing ones on file with those agencies to be in eCTD format beginning May 5, 2018.1
Good news! If your company relies on West DMFs to support their drug applications, you don’t have to worry. Since April 2016, all West DMFs held with CBER, CDER, and Health Canada are in eCTD format and conform to the agencies’ requirements.
West approached both agencies in 2014 with a proposal to establish eCTD requirements for packaging DMFs. Over the course of a year, we collaborated with each agency’s DMF content and electronic submissions experts to create a single set of requirements that were acceptable to industry and the agencies.
In addition, West drove agreements on procedures for managing the transition to eCTD in a way that limited impact to our customers, while minimizing the administrative burden for each regulatory agency.
As a result of our proactive approach, West filed the first eCTD packaging DMFs with both the FDA and Health Canada in late 2015.
Please note that we have worked out a plan with the three agencies to permit existing West LOA holders to continue using their current Letters of Authorization/Access (LOAs). If you are using an LOA that references the previous paper version of a West DMF, you do not need a new one.
Please also note that FDA requirements for eCTD DMFs do not apply to CDRH, which has opted not to accept them in this format at this time. West DMFs filed with this agency remain as paper documents.
The misson of West Regulatory Affairs is to provide customers with industry leading support for their global regulatory needs. Please click here to learn more.
The use of proteins as therapeutics has focused attention on the need to maintain the stability of these labile molecules during both storage and shipment. The trend in the pharmaceutical industry has been to package therapeutic proteins in prefillable syringes made of glass. However, some biologics are not stable in glass syringes due to sensitivity to adhesives used in their manufacture and to tungsten oxides generated during needle placement.
Cell-based therapies have emerged as a revolutionary approach in the field of regenerative medicine and as an anti-cancer therapeutic modality, offering potential treatments for a range of diseases. As the demand for cell-based therapies continues to grow, it is crucial to explore the current and future fill-finish packaging strategies to ensure the safety, efficacy, and accessibility of these therapies. Understanding the advantages and challenges associated with different modes for cell therapy packaging will allow drug manufacturers to choose a suitable system.
The complexity of bringing a combination product, such as an on-body delivery system (OBDS), to market cannot be overstated. Changing or unclear regulations are often cited by the industry as a major source of confusion which contributes to that complexity. However, continuous incorporation of updated standards and newly issued guidance documents during the development process can reduce risk, improve patient safety, save time and headaches when the submission date ultimately approaches.
Don’t miss an opportunity to meet with West experts at an upcoming tradeshow! Stop by our booth or one of our presentations to learn more about how West can help address common industry challenges with drug product packaging and delivery.
A key element of West’s commitment to a safe and efficient delivery of drug products is staying abreast of industry developments, and being prepared to help customers navigate them. Recently Dow Corning introduced a new product - Dow Corning® 366 35% Dimethicone NF Emulsion.
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