53 Total results for product and free and sample content found
TrialScope Disclose
07 Feb 2022
Disclosure requirements are numerous and ever evolving. Study sponsors need a transparency policy that addresses disclosure, transparency, and data sharing.
Topic Policy & Regulation
TrialScope Disclose
14 Sep 2021
Created by the European Medicines Agency (EMA). Stakeholders will use CTIS to: Submit and approve clinical trial applications (CTAs), Submit trial reports, results and notifications, Communicate centrally with the Member States Concerned (MSC) in the clinical trial
Topic Policy & Regulation Clinical Trials Clinical Trials Blog
Generics Bulletin
By David Wallace 08 Dec 2020
Reforms set out by the European Commission to better prepare the EU for future health crises must heed key lessons learned from experiences of the COVID-19 pandemic, such as the benefits of digitalization, Medicines for Europe has urged
Topic Coronavirus EU Policy & Regulation
Generics Bulletin
By David Wallace 29 Nov 2020
Reforms set out by the European Commission to better prepare the EU for future health crises must heed key lessons learned from experiences of the COVID-19 pandemic, such as the benefits of digitalization, Medicines for Europe has urged.
Topic Coronavirus EU Policy & Regulation
Scrip
By Brian Yang 27 Nov 2020
AbbVie’s HIV therapy Kaletra is now being used by the Chinese government to treat coronavirus-infected patients after a respiratory expert endorsed its use, while other pharma companies from Bayer to Innovent are showering support as China battles its worst virus outbreak since the SARS epidemic 17 years ago.
Pink Sheet
By Brenda Sandburg 27 Nov 2020
An interactive timeline shows the news of the past decade and the evolution of US FDA policies. Click on each year for a full list of events and see the accompanying article.
Topic FDA Policy & Regulation
Pink Sheet
By Cathy Kelly 18 Nov 2020
Regardless of the outcomes of the US elections, drug pricing is likely to take a back seat to COVID as policy focus. But the pandemic does offer pharma an opportunity for partnerships with payers on health outcomes. Commonwealth Fund’s Liz Fowler, South Capitol’s John O’Brien and ICER’s Steve Pearson discuss where drug pricing stands in public opinion, whether policies embraced by President Trump will have staying power, and the conditions needed in the policy environment for major change.
Pink Sheet
By Elizabeth Orr 09 Oct 2020
Textualist judges appointed by President Trump during his term may block a potential President Biden’s attempts to shift the government’s legal policies.
Pink Sheet
By Ian Schofield 02 Oct 2020
The UK medicines regulator has a “unique opportunity” to evaluate the systems it operates and to “do things differently", according to its long-term interim head, June Raine.
Topic Policy & Regulation Brexit
No Records Found
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