Pharmaceutical Technology
JUNE 9, 2025
For example, Recordati’s Cystadane (betaine) was centrally approved in 2007 but did not see its first reimbursement in Poland until 2023. In Romania, Novartis’s Atriance (nelarabine) was also centrally approved in 2007 but did not receive its first reimbursement in Romania until 2021.
European Pharmaceutical Review
JULY 5, 2023
The long-awaited PDA TR 43 report provides an approach to a quality decision-making process and represents best practices for the identification and classification of visual nonconformities for (empty) glass containers as pharmaceutical product packaging.
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FDA Law Blog: Biosimilars
JULY 10, 2025
However, the vast majority of the CRLs posted in the openFDA database are already available in the action packages posted on FDA’s Drugs@FDA database and approved biologics product pages. If a drug is approved, section 916 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (codified at 21 U.S.C. §
pharmaphorum
OCTOBER 22, 2020
Purdue filed for bankruptcy last year, after it proposed a separate $10 to $12 billion settlement package to resolve those lawsuits. It admitted to bribing two doctors to write more prescriptions of OxyContin as well as other drugs between June 2009 and March 2017. Image by Gerd Altmann from Pixabay.
RX Note
JUNE 8, 2023
In the past, package inserts were not always reliable sources of information regarding medication safety during lactation. Notable exceptions are heparin and insulin which are too large to cross biological membranes. As a general rule, breastfeeding is considered acceptable when the relative infant dose is <10%.
FDA Law Blog: Biosimilars
JULY 15, 2025
This definition is familiar to drug manufacturers because it is substantially identical to the definition that has existed under the MDRP since 2007. CMS proposes to add a definition of “bundled arrangement” to the existing ASP regulations at 42 C.F.R. See 42 CFR 447.502.
pharmaphorum
APRIL 11, 2022
Garabedian and his team plan to support VivoSense, not just with their funding package but with their industry network and connectivity. “We He served as the President and CEO of Sarepta Therapeutics from 2011 to 2015 and led corporate strategy for Celgene from 2007 to 2010 ( see more on LinkedIn ). This brings us to VivoSense.
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