FDA Approval Generic Drugs Packaging Production 
Camargo
OCTOBER 14, 2021
The expanded use of the INitial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs (INTERACT) meeting : INTERACT meetings are intended to facilitate IND-enabling efforts where a sponsor is facing a novel, challenging issue that might delay the progress of the product towards entry into the clinic in the absence of this early FDA input.
Pharmacy Checkers
FEBRUARY 14, 2020
Apparently, the FDA had approved Budeprion XL 300mg after undergoing no actual testing. In fact, they asked ConsumerLab.com, sister company to PharmacyChecker, to test the product. Despite the small but mighty uproar on lack of true generic equivalence, this is the case with Wellbutrin. So, the Graedons spoke up!
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Camargo
DECEMBER 9, 2020
The FDA’s halt of onsite inspections has created a wealth of problems. Camargo is currently involved with no less than three product applications that are stalled because the FDA is requiring inspections before the application can be approved (assuming a satisfactory outcome). Evergreening Orphan Drugs May Be Over.
FDA Law Blog
AUGUST 17, 2023
FDA-2023-P-0313 and FDA-2023-P-0344 ) regarding its product Hetlioz (tasimelteon). Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found in 21 U.S.C. §
Pharmacy Checkers
JANUARY 10, 2020
This post is mostly a story about a very well manufactured, safe and effective, foreign version of an FDA-approved drug. These drugs are normally far less expensive than the FDA-approved version sold in the U.S. That word “same” is hard to answer when it comes to prescription drugs.
XTalks
AUGUST 2, 2023
Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. They are committed to capitalizing on growth opportunities primarily through the advancement of their own product pipeline and constantly improving their existing products, as well as through business development activities.
Pharmacy Checkers
DECEMBER 12, 2019
The GAO’s preliminary analysis on inspections brings back into light what Katherine Eban so passionately – and dramatically – exposed in her book Bottle of Lies: The Inside Story of the Generic Drug Boom.” Clearly, the FDA acknowledges the relative strength of the EU on drug safety. and the EU are very similar.
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