Blog
RSS FeedPosted by Michael Wonder on 16 Sep 2019
FDA seeks input on product-specific guidances to facilitate generic drug development
16 September 2019 - Today, FDA published 53 product-specific guidances (PSGs) – 34 new guidances and 19 revised guidances, including ...
Posted by Michael Wonder on 13 Sep 2019
Taranaki man fearful drug funding change will bring back a life of seizures
13 September 2019 - For three years now a normal life has cost Nick Coulton $10 every three months. From ...
Posted by Michael Wonder on 29 Aug 2019
U.S. FDA approves Mylan generic of Lilly lung cancer drug Alimta
29 August 2019 - The U.S. Food and Drug Administration on Thursday granted Mylan tentative approval for its generic version ...
Posted by Michael Wonder on 20 Aug 2019
Sarepta Therapeutics receives complete response letter from the US FDA for golodirsen new drug application
19 August 2019 - Sarepta Therapeutics today announced it had received a complete response letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 15 Aug 2019
Growing numbers of priority and competitive ANDAs under review as approvals trickle in
15 August 2019 - The US FDA on Wednesday released quarterly data on two of its programs aimed at increasing generic ...
Posted by Michael Wonder on 14 Aug 2019
Canadians benefitting from substantially lower generic drug prices
14 August 2019 - Latest agreement between public payers and the Canadian generic industry closes gap with international prices. ...
Posted by Michael Wonder on 07 Aug 2019
FDA should take additional steps to address factors that may affect approval rates in the first review cycle
7 August 2019 - Companies that make generic drugs—which have the same active ingredients as brand-name drugs—have to apply for ...
Posted by Michael Wonder on 30 Jul 2019
Reforms to the generic medicine market authorisation process
30 July 2019 - The TGA would like to thank respondents who provided submissions in response to the public consultation ...
Posted by Michael Wonder on 22 Jul 2019
FDA approves first generics of Lyrica
22 July 2019 - On July 19, the U.S. FDA approved multiple applications for first generics of Lyrica (pregabalin) for the ...
Posted by Michael Wonder on 16 Jul 2019
Why isn’t insulin a complex generic? PA representative asks the FDA
16 July 2019 - Republican Mike Kelly (R-PA) sent a letter Tuesday to US FDA Acting Commissioner Ned Sharpless questioning ...
Posted by Michael Wonder on 15 Jul 2019
China to soften generic drug buying program
15 July 2019 - Chinese drug makers jumped on Monday after a local news report that a centralised drug procurement ...
Posted by Michael Wonder on 10 Jul 2019
FDA announces new efforts to expedite generic drug development and marketing to improve patient access to medicines
10 July 2019 - Today, the U.S. FDA announced a draft guidance, Harmonizing Compendial Standards With Drug Application Approval Using the ...
Posted by Michael Wonder on 27 Jun 2019
Sneaky deals are keeping cheaper generic medicines off the market
27 June 2019 - It’s bad enough drug companies charge sky-high prices for brand-name prescription meds and raise those prices ...
Posted by Michael Wonder on 23 Jun 2019
Epilepsy medicine worry
24 June 2019 - A controversial change of epilepsy drug funding could see her and thousands of other people with ...
Posted by Michael Wonder on 19 Jun 2019
Atomoxetine – delay in change of funded brand and open access
19 June 2019 - PHARMAC is advising all interested parties that there will be a delay in the listing of ...