Results For "fda"

Reflections on the Recent ICH E11A Pediatric Extrapolation Guideline Blog Post

The ICH E11A draft Guideline on Paediatric Extrapolation was released on 4 April 2022 entering a public consultation phase. This guideline has several objectives. While aiming to harmonize methodologies and approaches for…

Providing Around-the-Clock Regulatory Support While Enhancing Team Chemistry Blog Post

Advaxis Inc. is devoted to the discovery, development, and commercialization of immunotherapies based on a technology platform which uses engineered Listeria monocytogenes. The company is headquartered in Monmouth Junction, New...

PBPK Modeling in Adults Enables DDI Risk Assessment in Children with SMA Blog Post

In 2020, the US FDA approved Risdiplam (Evrysdi®) as the first orally administered drug to treat SMA in patients ≥2 months old, followed by the European Medicine Agency. Risdiplam addresses...

Leveraging Clinical Data from One Rare Disease to Support Drug Approval for Another Blog Post

非典型溶血性尿毒症综合征（aHUS）是一种极其罕见的遗传疾病，会导致全身小血管内异常血凝块的形成，从而导致肾衰竭、其他器官损伤和过早死亡。...

The Utility of Model-Informed Drug Development for Rare Diseases Blog Post

模型引导的药物开发（MIDD）是一个紧密结合的生态系统网络，可以无缝定位候选新药，同时最大限度地减少技术和监管成功的不确定性。Indeed, MIDD affords…

Ask Me Anything: Career Opportunities in Regulatory & Medical Writing Blog Post

Have you ever wondered what it would be like to be a Regulatory or Medical Writer in the pharmaceutical industry? Certara’s global regulatory writing team includes PhDs, MDs, PharmDs, scientists,…

Project Optimus Resource Portal Page

Project Optimus Resource Portal With the evolving regulatory landscape in oncology, we know that it is critical to stay on top of the latest news and be informed. 我们是一支由...

P21 Adds Support for CDISC Open Rules Engine (CORE) Blog Post

P21 is proud to announce that support for CDISC Open Rules Engine (CORE) is now available in P21 Community 4.0. We have expanded CORE’s reference implementation to let you execute machine-readable...

Pinnacle 21 Releases P21 Community 4.0 Blog Post

As of 2022 年 4 月 25 日, we have released P21 Community 4.0 to general availability! Install it now from our Downloads page. P21C 4.0 is the first major release of this application…

Accelerating Oncology Drug Development with Biosimulation and Regulatory Strategy Page

Accelerating Oncology Drug Development with Biosimulation and Regulatory Strategy Trust the experts who advanced 500+ oncology projects With more than 80% of novel compounds to treat cancer coming from emerging...