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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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. ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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Epilepsy medicine worry

24 June 2019 - A controversial change of epilepsy drug funding could see her and thousands of other people with ...

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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 ...

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