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RSS FeedPosted by Michael Wonder on 24 Jun 2020
The new Janet: the FDA turns to a quiet problem-solver who brings expertise — and a little controversy
23 June 2020 - Janet Woodcock, one of the FDA’s most powerful regulators, has an almost mythic reputation and an ...
Posted by Michael Wonder on 24 Jun 2020
Global regulators discuss data requirements for phase 3 trials of COVID-19 vaccines
24 June 2020 - Under the umbrella of the International Coalition of Medicines Regulatory Authorities, international regulators discussed COVID-19 vaccine ...
Posted by Michael Wonder on 23 Jun 2020
FDA maintains the pace of meeting its goals on applications for medical products during the pandemic
23 June 2020 - One of the challenges facing the FDA during the COVID-19 pandemic is how to ensure the ...
Posted by Michael Wonder on 23 Jun 2020
Academia developing medicines for rare diseases to receive free EMA scientific advice
23 June 2020 - To further encourage the development of treatments for rare diseases, EMA will waive all fees for ...
Posted by Michael Wonder on 23 Jun 2020
Law makers push COVID-19 bills to prevent price gouging, track federal funds used to discover drugs
22 June 2020 - Amid ongoing concern that COVID-19 therapies and vaccines may be unaffordable, a bipartisan group of lawmakers ...
Posted by Michael Wonder on 23 Jun 2020
Submissions received: fees and charges proposal 2020-21
23 June 2020 - On 20 January 2020, the Therapeutic Goods Administration (TGA) released on its website a consultation paper, ...
Posted by Michael Wonder on 22 Jun 2020
PMPRB publishes new draft guidelines, launches 30 day consultation
22 June 2020 - As reported earlier this month, the Patented Medicine Prices Review Board has published a new draft ...
Posted by Michael Wonder on 22 Jun 2020
Proposed legislation to stabilise ACA threatens health care innovation
22 June 2020 - This week, the Democratic led House of Representatives may introduce legislation that seeks to stabilise the ...
Posted by Michael Wonder on 22 Jun 2020
European Commission, EMA and FDA agree new priorities to strengthen their collaboration on medicines
22 June 2020 - Senior officials from the European Commission, EMA and the United States FDA held their 2020 bilateral ...
Posted by Michael Wonder on 21 Jun 2020
Coronavirus attacks the lungs. A federal agency just halted funding for new lung treatments.
19 June 2020 - The shift, quietly disclosed on a government website, highlights how the Trump administration is favouring development of ...
Posted by Michael Wonder on 18 Jun 2020
Fees and charges: summary from 1 July 2020
18 June 2020 - The TGA is required to recover its costs for all activities that fall within the scope of ...
Posted by Michael Wonder on 18 Jun 2020
Government authorises use of dexamethasone for COVID-19
18 June 2020 - The UK has authorised immediate use of dexamethasone on the NHS, widening access to the first ...
Posted by Michael Wonder on 18 Jun 2020
International regulators stress value of safe and effective vaccines
18 June 2020 - EMA has endorsed two statements about the importance, safety and effectiveness of vaccines published today by the ...
Posted by Michael Wonder on 18 Jun 2020
Trump administration seeks to encourage ‘value-based’ drug pricing deals with new proposal
17 June 2020 - The Trump administration wants to revamp certain Medicaid rules about drug prices in hopes of encouraging ...
Posted by Michael Wonder on 17 Jun 2020
Identifying the risks of unproven regenerative medicine therapies
17 June 2020 - In the middle of the coronavirus disease 2019 public health response, many priorities are currently competing for ...