Generic Drugs Pharmacy Production Regulation 
XTalks
FEBRUARY 8, 2021
While the approval pathway for biosimilar products was established 12 years ago, there are still misconceptions about how biosimilars are approved, biosimilarity versus interchangeable status and which patients can be treated with biosimilars. Biosimilars are the “generic” drugs of the biopharma world. What is a Biosimilar?
The Pharma Data
JULY 29, 2021
Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. for the treatment of diabetes. Biosimilars marketed in the U.S.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
FDA Law Blog
JANUARY 22, 2024
Led by former federal prosecutor Jill Furman, OC is charged with shielding consumers “from poor quality, unsafe, and ineffective drugs through compliance strategies and risk-based enforcement actions.” Drug Supply Chain. This is another area in which FDA works with industry to try to ensure voluntary compliance from regulated entities.
Pharmacy Checkers
SEPTEMBER 10, 2020
online pharmacy that actually tests the quality of medication it sends to patients and apparently, to my delight, they support drug importation as a policy to lower costs. When people go online or to their local Walgreens to buy prescription drugs domestically, they are largely relying on the regulatory strength of the U.S.
Pharmacy Checkers
JANUARY 10, 2020
costs only $90 for a three-month supply at the lowest-cost PharmacyChecker-accredited international online pharmacy: a savings of 71%. We know there are many doctors, nurses and other prescribing medical professionals who recommend PharmacyChecker or have learned of trusted licensed foreign pharmacies though their own research.
FDA Law Blog
JUNE 16, 2023
Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers. We address each below.
The Pharma Data
MAY 7, 2021
International regulators and WHO call for wider public access to clinical data ( EMA ). EU regulator begins real-time review of GSK-Vir COVID-19 antibody drug ( Reuters ) ( Press ). Two drug makers, two commercial launches — with divergent results ( STAT ). Generic Drug Cos. .
Expert insights. Personalized for you.
78 
Let's personalize your content