Tag: 規制関連
サターラ、承認申請プロセスを効率化する最新ソフトウェアSynchrogenix™ Writerを販売開始
Cloud-based and validated regulatory software automates and advances quality of patient narratives Princeton, N.J., 2021年9月30日 – Certara, a global leader in biosimulation, today announced the launch of Synchrogenix™ Writer, a new regulatory SaaS product that expedites the authoring and review of patient narratives. Patient narratives describe adverse events or adverse drug reactions and … Continued
Understanding Key Components of a Clinical Evaluation
In 2016, the European Commission (EC) released MEDDEV 2.7/1 Revision 4 (MEDDEV) Clinical Evaluation: A Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC, which was the first indication of sweeping regulatory changes that would occur in Europe affecting medical devices. This guideline was published and went into immediate effect without a transition … Continued
DIA Canada
2021 RAPS Convergence
Takeover of lifecycle maintenance of investigational new drug applications
Thought Leadership Series: Leveraging FDA expedited review programs
2021年8月25日 at 2:00 p.m. ET The U.S. FDA offers four distinct programs to speed the development and availability of drugs that address an unmet medical need in the treatment of a serious or life-threatening conditions: Priority Review, Accelerated Approval, Fast Track, and Breakthrough Therapy. Additionally, other programs, such as the Regenerative Medicine Advanced … Continued
Why You Should Participate in the Voluntary FDA Oncology Center of Excellence Assessment Aid Program
In 2018, the FDA’s Oncology Center of Excellence developed an Assessment Aid document to help facilitate review of New Drug Applications (NDAs)/Biologics License Applications (BLAs) (including supplements) submitted to the Center for Drug Evaluation and Research’s (CDER’s) Office of Oncology Diseases (OOD). Providing the Assessment Aid with your NDA/BLA is voluntary. As noted by the … Continued
Strategic Planning and technology to support a rolling BLA submission under tight timelines
Small Molecules, Biologics, and Vaccines: Three Uniquely Divergent Roads to FDA CMC Approval
In chemistry, manufacturing, and controls (CMC) regulatory writing, there is a difference in the level of detail required for New Drug Applications (NDAs) and Biologic License Application (BLAs) supporting different types of products. The expectations tend to diminish as time elapses and the regulatory authority becomes more familiar with a specific type of medicinal product. … Continued
