Generic Drugs

Sep 09, 2016
If FDA’s proposed generic-drug labeling rule is passed in 2017, generic drug companies would need documented processes for safety tracking and label updates.
Sep 02, 2016
Pharmaceutical Technology
Companies may potentially accelerate the approval of generic drugs by avoiding deficiencies in ANDA submissions.
Sep 01, 2016
By Pharmaceutical Technology Editors
GPhA and PBOA commend agreement to reauthorize Generic Drug User Fee Amendments.
Aug 30, 2016
Can Competition Block Excessive Pharma Price Hikes? EpiPen Saga Shows It’s Hard
Aug 18, 2016
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
Fresenius Kabi will add to its generic, sterile injectable manufacturing at its Melrose Park, Illinois site.
Aug 15, 2016
By Pharmaceutical Technology Editors
The agency has adopted guidelines on the pharmacovigilance of biological drugs.
Jul 27, 2016
FDA and industry seek speedy Congressional approval of new user fee plan.
Jul 08, 2016
A Federal Circuit court ruled biosimilar makers must wait 180 days after receiving FDA approval before bringing drugs to market.
Jul 06, 2016
By Pharmaceutical Technology Editors
Teligent is expanding its manufacturing and R&D complex in New Jersey.
Jun 15, 2016
A study published in BMJ indicates that rheumatic patients with anti-infliximab antibodies may have a similar cross reaction to infliximab biosimilars.
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