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Brexit Impact on EudraCT Postings

The European Commission published a notice to stakeholders on September 6, reminding pharmaceutical companies of some unexpected impacts of Brexit in multiple areas, including the submission of clinical trial information to EudraCT. The submission of certain clinical trial information to the European Union (EU) database is a provision of an EU law which will no … Continued

EMA Policy 0070 External Guidance Update

Even though the European Medicines Agency (EMA) has suspended publication of clinical data through Policy 0070 due to its Brexit business continuity plan, EMA posted a Policy 0070 external guidance update on November 11, 2018. Revision 4 is now in effect. Policy 0070 External Guidance Update – Major Changes Several major changes are noted in this … Continued

Do You Know the Requirements for Medical Devices Post Brexit?

The United Kingdom (UK) officially left the European Union (EU) on 31 January 2020. According to the withdrawal agreement, it is now officially a third country to the EU and no longer participates in EU decision making. The agreement established a transition period that ended on 31 December 2020.1 As a result, the Medicines and … Continued

Are you ready for 2021? – Remember Brexit in Your Pediatric Planning

By Eva Berglund When writing this, it’s just before Christmas and 14 days are left in 2020. As we all know, Brexit—the withdrawal of the United Kingdom from the European Union— is coming up and thereby new rules for pediatric drug developers come into place for the UK in 2021. Transitional rules The EU uses … Continued

FDA Seeking Feedback on Drug Approval Transparency and Disclosure Efforts

Background In 2018, the Food and Drug Administration (FDA) launched a pilot to test the capability of publicly posting summaries of the safety and efficacy information that is used to make drug approval decisions. This followed suit with the European Medicine Agency’s (EMA) Policy 0070 that launched in 2015 and Health Canada’s (HC) Clinical Information … Continued

Major Medical Device Regulatory Changes Taking Shape in 3 Key Geographies

Medical device manufacturers are constantly navigating the regulatory world. And like most other industries in 2022 and beyond, that world looks to be more complex and dynamic than ever. Particularly in the EU, UK, and US, change is unfolding at an unprecedented pace and with greater stakes as governing bodies envision and adjust to the … Continued

Drug Safety for Targeted Cancer Treatment

Certara scientists performed DDI analysis and C-QTc modeling for a client seeking to demonstrate the safety of a targeted treatment for breast cancer.

Heartbreaking Works of Staggering Genius: Cardiac Safety for Oncology

I could give you some of facts and figures about cancer. Like the fact that the American Cancer Society estimates there will be 1,658,370 new cancer cases diagnosed and 589,430 cancer deaths in the US this year. Or that pancreatic cancer has only a 5-year survival rate of 5%. But, these statistics belie the heartbreaking reality … Continued

Covid-19 Vaccine: How Private-Equity Portfolio Companies Played a Role

By Lauren CooperPhoto Credit: Copyright Nasdaq 2021 Governments, nonprofits and healthcare workers are trying to get as many people vaccinated against Covid-19 as possible. Private-equity portfolio companies have been involved in nearly every step of the process (…)

Pharmacogenetics—Expectations and Reality

Thirty years have passed since Mike Rawlins, the current chairman of the National Institute for Clinical Excellence (NICE), coauthored a small but perfectly formed book entitled Variability in Human Drug Response. In the interim we have witnessed the waxing and waning of clinical pharmacology and the inexorable rise of genomic medicine. Genomic medicine has generated many … Continued
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