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Senior Writer
Washington DC, USA
25+ years of experience
Pink Sheet
By Derrick Gingery 14 Jul 2021
US position remains that boosters are not needed yet, but CBER Director Peter Marks says regulators are discussing how to harmonize applications for booster shots.
Pink Sheet
By Derrick Gingery 08 Dec 2020
As vaccines near availability, Moncef Slaoui says his full-time role at OWS may be ending. He has not met with the Biden Transition team, but notes that other Warp Speed officials have.
Pink Sheet
By Derrick Gingery 29 Nov 2020
Azar says ACIP’s prioritization recommendations should carry weight, but states will be final arbiter of who is vaccinated
Topic Vaccines Coronavirus Distribution
Pink Sheet
By Derrick Gingery 27 Nov 2020
The FDA is curiously not one of the HHS entities coordinating the US response to the outbreak, but must monitor for manufacturing disruptions and shortages, as well as approve new treatments and diagnostics.
Pink Sheet
By Derrick Gingery 09 Oct 2020
‘Senator, please stop undermining confidence in a vaccine,’ Pence says when confronted with the accusation that the administration is politicizing the COVID vaccine development effort.
Pink Sheet
By Derrick Gingery 09 Oct 2020
The median of two months of follow-up is not absolute, but agency flexibility is limited.
Topic Coronavirus Vaccines
Pink Sheet
By Derrick Gingery 21 Sep 2020
CBER director said that all the manufacturing data may not be available, but the safety and efficacy data needed for a BLA are expected before an emergency use authorization is granted.
Topic Coronavirus Vaccines
Scrip
By Derrick Gingery 01 Jul 2020
Several countries already are calling about orders, as the company prepares to begin a Phase III trial of its mRNA coronavirus vaccine candidate.
Topic Coronavirus Vaccines
Pink Sheet
By Derrick Gingery 15 Jan 2020
The former US FDA principal deputy commissioner argues that accelerated approval, fast track and breakthrough designation standards may need updating, along with orphan and pediatric exclusivity requirements, to enhance the programs' efficacy.
Pink Sheet
By Derrick Gingery 14 Aug 2019
Gene therapy should remain on the market, FDA says, but Novartis could face civil or criminal penalties. Firm knew of problems before approval.
Topic FDA Company Analysis
Pink Sheet
By Derrick Gingery 02 Jul 2019
In his first speech to an outside group, Sharpless strikes a collaborative tone, saying he expects to listen to the advice of the FDA bar, as well as his own experts.
Topic FDA
Pink Sheet
By Derrick Gingery 02 Jul 2019
More than 300 generic drug applications might be officially filed when the shutdown ends, substantially increasing stress on assessors and other Office of Generic Drugs staff.
Topic US Shutdown FDA
Medtech Insight
By Derrick Gingery 02 Jul 2019
Under a new regulatory platform, drugs could soon be approved with accompanying software applications that could monitor adverse events or patient compliance without a separate pre-market device review.
Topic Digital Health
Pink Sheet
By Derrick Gingery 28 May 2019
President Trump touts CMS proposal that would peg Part B prices to an international index in the hopes of lowering US costs; industry calls it foreign price controls and warns it will hinder access.
Pink Sheet
By Derrick Gingery 22 Aug 2018
Reviewer expertise may be better leveraged in more focused roles, but basic tenets of rare disease program should not fundamentally change as part of proposed Office of New Drugs reorganization.
Topic FDA
Pink Sheet
25 Jul 2022
Pink Sheet
20 Jul 2022
Pink Sheet
20 Jul 2022
Pink Sheet
18 Jul 2022
Pink Sheet
14 Jul 2022
HBW Insight
14 Jul 2022
Pink Sheet
13 Jul 2022
Pink Sheet
12 Jul 2022
Pink Sheet
11 Jul 2022
Pink Sheet
07 Jul 2022
Pink Sheet
05 Jul 2022
Pink Sheet
04 Jul 2022
Pink Sheet
27 Jun 2022
HBW Insight
26 Jun 2022
Pink Sheet
21 Jun 2022
