Blog
RSS FeedPosted by Michael Wonder on 21 Oct 2021
FDA issues draft guidance for industry on data standards for drug and biological product submissions containing real world data
21 October 2021 - Today, the U.S. FDA issued a draft guidance for industry titled Data Standards for Drug and Biological ...
Posted by Michael Wonder on 20 Oct 2021
FDA pre-submission for saliva based glucose test to replace invasive finger prick
19 October 2021 - The iQ Group Global, on behalf of its subsidiary, Life Science Biosensor Diagnostics, is pleased to announce ...
Posted by Michael Wonder on 19 Oct 2021
Democrats’ drug pricing reforms aren’t what they seem
19 October 2021 - As part of their spending bill, Congressional Democrats are advancing legislation that'll empower Medicare to "negotiate" ...
Posted by Michael Wonder on 19 Oct 2021
FDA to allow ‘mix and match’ approach for Covid booster shots
18 October 2021 - The agency may act this week, when it is expected to authorise booster shots for recipients of ...
Posted by Michael Wonder on 18 Oct 2021
On COVID-19 booster shots, the FDA has overstepped its role
18 October 2021 - Booster shots for all adults six months after being vaccinated against COVID-19 are safe, effective, and ...
Posted by Michael Wonder on 14 Oct 2021
Biden eyeing FDA veteran Robert Califf to lead the agency
14 October 2021 - If nominated and confirmed, Califf would take over an agency poised to make key decisions on coronavirus ...
Posted by Michael Wonder on 13 Oct 2021
Why we can have both innovative drugs and lower drug prices
13 October 2021 - The debate in Congress over negotiating drug prices is based on a phony premise that higher prices ...
Posted by Michael Wonder on 11 Oct 2021
Medicare drug pricing debate pits savings against innovation
11 October 2021 - Proposal to allow Medicare to negotiate for lower prescription drug prices is central to Democrats’ health care, ...
Posted by Michael Wonder on 10 Oct 2021
New FDA chief can't come soon enough for beleaguered agency
8 October 2021 - One of the leading agencies in the government’s fight against COVID-19 is finally on the verge of ...
Posted by Michael Wonder on 07 Oct 2021
The FDA should better regulate medical algorithms
7 October 2021 - Most do not require the agency’s approval, and those that do often don’t require clinical trials. ...
Posted by Michael Wonder on 07 Oct 2021
FDA still without a permanent leader as clock ticks down on acting head
7 October 2021 - The clock is ticking down on the time President Joe Biden has to appoint a permanent ...
Posted by Michael Wonder on 07 Oct 2021
FDA issues final order and guidance on surgical staplers and staples for internal use
7 October 2021 - Today, the U.S. FDA announced several actions related to surgical stapler and staple regulation and safety. ...
Posted by Michael Wonder on 07 Oct 2021
Ban on negotiating Medicare drug prices under pressure
7 October 2021 - Negotiating Medicare drug prices is a linchpin of President Joe Biden's ambitious health care agenda. ...
Posted by Michael Wonder on 05 Oct 2021
The Product Monograph for Protopic has been updated
4 October 2021 - LEO Pharma Inc. today announced that Health Canada has approved an update to the Product Monograph of ...
Posted by Michael Wonder on 05 Oct 2021
FDA’s naming rule for biosimilars has undermined Congress and health care
4 October 2021 - I recently tried to order white blood cell growth factor (pegfilgrastim) biosimilar for one of my ...