Washington, June 4 (Ians) In a bid to ease the ongoing shortage of chemotherapy in the US, the country’s Food and Drug Administration (Fda) has allowed for a temporary import of the cancer drug made in China.
Chinese drug maker Qilu Pharmaceutical has received the Fda approval for their cisplatin injections, CNBC reported.
The injectable medication will be distributed in the US in 50-milligram vials on a temporary basis by Canadian drug maker Apotex. It will be available for order by health care providers starting Tuesday.
“The Fda recognises the importance of a stable, safe supply of critical drugs used in oncology, especially those used in potentially curative or life-extending situations,” Fda Commissioner Dr Robert Califf said on Twitter.
“Today, we’ve taken steps for temporary importation of certain foreign-approved versions of cisplatin products from Fda-registered facilities and used regulatory discretion for continued supply of other cisplatin and carboplatin products to help meet patient needs.
Chinese drug maker Qilu Pharmaceutical has received the Fda approval for their cisplatin injections, CNBC reported.
The injectable medication will be distributed in the US in 50-milligram vials on a temporary basis by Canadian drug maker Apotex. It will be available for order by health care providers starting Tuesday.
“The Fda recognises the importance of a stable, safe supply of critical drugs used in oncology, especially those used in potentially curative or life-extending situations,” Fda Commissioner Dr Robert Califf said on Twitter.
“Today, we’ve taken steps for temporary importation of certain foreign-approved versions of cisplatin products from Fda-registered facilities and used regulatory discretion for continued supply of other cisplatin and carboplatin products to help meet patient needs.
- 6/4/2023
- by Agency News Desk
- GlamSham
A federal district court judge in Texas has issued an injunction suspending distribution of mifepristone — a critical component in the two-step abortion pill regimen — nationwide. It’s hard to overstate the magnitude of the order, which could make the drug used in most abortions in America unavailable to women throughout the country, even in states where abortion is legal.
One of the most glaring flaws in the argument that anti-abortion advocates advanced in the case revolved around timing: There is a six-year statute of limitations to challenge Fda authorization and...
One of the most glaring flaws in the argument that anti-abortion advocates advanced in the case revolved around timing: There is a six-year statute of limitations to challenge Fda authorization and...
- 4/7/2023
- by Tessa Stuart
- Rollingstone.com
New York, Aug 29 (Ians) The US Food and Drug Administration (Fda) is expected to approve new covid-19 booster shots for newer Omicron strains this week, making them accessible to people in the country before any human testing is finished, the media reported.
The vaccines have been modified to target the most recent Omicron variant, but the US Fda won’t have finished testing them on humans, the Daily Mail reported citing The Wall Street Journal.
The report mentioned that the Fda is instead relying on information from other sources, such as mice study and data from previous immunisation.
“Real world evidence from the current mRNA Covid-19 vaccines, which have been administered to millions of individuals, show us that the vaccines are safe,” Fda Commissioner Robert Califf said in a tweet last week.
The official also wrote that the Fda will rely on the totality of the available evidence in making a decision.
The vaccines have been modified to target the most recent Omicron variant, but the US Fda won’t have finished testing them on humans, the Daily Mail reported citing The Wall Street Journal.
The report mentioned that the Fda is instead relying on information from other sources, such as mice study and data from previous immunisation.
“Real world evidence from the current mRNA Covid-19 vaccines, which have been administered to millions of individuals, show us that the vaccines are safe,” Fda Commissioner Robert Califf said in a tweet last week.
The official also wrote that the Fda will rely on the totality of the available evidence in making a decision.
- 8/29/2022
- by Glamsham Bureau
- GlamSham
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