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RSS FeedPosted 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 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 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 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10 July 2019 - Today, the U.S. FDA announced a draft guidance, Harmonizing Compendial Standards With Drug Application Approval Using the ...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 18 Jun 2019
FDA releases new data to help generic drug competitors
18 June 2019 - Generic drug applicants will now have more information from the US FDA when deciding whether to ...
Posted by Michael Wonder on 18 Jun 2019
Statement on a new effort to improve transparency and predictability for generic drug applicants to help increase timely access to high-quality, lower cost generic drugs
18 June 2019 - The U.S. FDA is committed to helping facilitate American patients’ access to lower-cost generic medicines by ...
Posted by Michael Wonder on 20 May 2019
FDA's strengthened global inspection program helps ensure generic drug safety
17 May 2019 - Consumers must have confidence in the safety and quality of generic medicines. ...
Posted by Michael Wonder on 13 May 2019
Safety, efficacy, and quality remain top priorities as we continue our work to expand access to cost-saving generic drugs for the American public
13 May 2019 - Millions of Americans have difficulty paying for their prescription medications. ...
Posted by Michael Wonder on 13 May 2019
Intellipharmaceutics announces FDA approval for generic Pristiq
10 May 2019 - Intellipharmaceutics announced today that it has received approval from the U.S. FDA for the Company's abbreviated new ...
Posted by Michael Wonder on 12 May 2019
Teva and other generic drug makers inflated prices up to 1,000%, State prosecutors say
11 May 2019 - According to a new lawsuit, generic medications including oral antibiotics, blood thinners, cancer drugs, contraceptives and HIV ...
Posted by Michael Wonder on 10 May 2019
Allegations of widespread fraud raise questions about the safety of generic drugs made overseas
10 May 2019 - It is something we've all heard before: generic drugs are the same as brand-name drugs. They ...
Posted by Michael Wonder on 08 May 2019
They were supposed to talk about the patent system driving up drug prices. But most lawmakers got distracted by small tweaks.
7 May 2019 - If there was any hope that Congress might overhaul the way this country doles out the ...
Posted by Michael Wonder on 20 Apr 2019
FDA approves first generic naloxone nasal spray to treat opioid overdose
19 April 2019 - Agency is also taking new steps to support development of over-the-counter and additional generics of naloxone to ...
Posted by Michael Wonder on 12 Mar 2019
FDA approves a new generic valsartan
12 March 2019 - Today, the U.S. FDA approved a new generic of Diovan (valsartan). ...