Canada is taking action after the FDA approved Florida's plan to import medicines from its northern neighbor

 



Is drug import plan from Canada stalled, days after FDA approved Florida's import plan? Canada doesn't seem too happy, with drug imports by one of the largest U.S. states slowing Canada's drug import plan. We will take all necessary measures to avoid disrupting supply. Health Canada's statement on the FDA's decision on Florida's bulk drug import plan, released on January 8, 2024, makes their concerns abundantly clear.Click here for FDA compliance consultant.

If Canada is so worried about Florida, how much do you think it would raise the hairs on the back of your neck if another, even larger state's plan was also approved by the FDA ? Canada's statement reads: “Regulations have come into force under the  Food and Drugs Act that prohibit the sale of certain medicines intended for the Canadian market for consumption outside Canada. Such sales may result in drug shortages or Where drug shortages could worsen” in Canada. This includes all drugs eligible for bulk import into the United States, including those listed in Florida's bulk import program and other U.S. states' future import programs. ” It took several years of review and approval, but now faces a determined position from Canada that threatens to derail Florida's plans before the first medicines can even cross the border.

 

 

The New Drug Approval Report is very insightful and this statistic provides insight into what PDUFA and subsequent iterations have done over the years to improve new drug approval since its inception in 1992. Although GDUFA is only in its third year since it first came into force on October 1, 2012, one might think that its requirements should be known , but the Abbreviated New Drug Application typically goes through at least two review cycles. Most companies had previously been approved for three or more cycles. Given that there are other unique regulatory and scientific questions that need to be answered regarding generic drugs (e.g., equity nature of ANDA products, labeling issues related to spin-offs, unique bioequivalence), the reason is still not clear to me. This is the industry and OGD can't seem to increase his ANDA approval percentage in the first cycle. Is it just me or do others have the same question?

Comments

Post a Comment

Popular posts from this blog

NGFW vs. Traditional Firewalls

Image
  Traditional firewalls and NGFWs are both designed to detect and block malicious or unwanted traffic that crosses network boundaries. However, this occurs at different levels of the TCP/IP network protocol stack. Traditional firewalls operate primarily at the TCP and IP layers of the protocol stack. They restrict the types of traffic that can enter or leave their protected network by checking the IP addresses and port numbers of inbound and outbound packets. However, their inability to see the contents of network packets leaves them blind to many modern threats. NGFWs, on the other hand, operate at the application layer of the protocol stack. Their understanding of application traffic and ability to decrypt encrypted traffic streams allows them to identify and control application traffic and also block a wider range of threats. And unlike traditional firewall policies based on IP and service ports, NGFWs integrate user and machine identity into security policies, which bet...
Read more

Network Convergence System

Image
    Cloud Scaling for WAN Aggregation Arista network Convergence System 5500 Series offers industry-leading density of routed 400 Gigabit Ethernet (400GE) and 100GE ports for scaled-up WAN aggregation To do. The NCS 5500 Series is designed to scale efficiently across enterprise, web, and service provider data centers and WAN and aggregation networks.   Product Overview Cisco Network Convergence System “NCS” The 5500 Modular Chassis series includes the Cisco NCS 5504 Modular Chassis, Cisco NCS 5508 Modular Chassis, and Cisco NCS 5516 Modular Chassis . The Cisco NCS 5504 supports up to four line cards, six switch fabric cards, two routing processors, two system controllers, three fan trays, and four power supplies. The Cisco NCS 5508 supports up to 8 line cards, 6 switch fabric cards, 2 routing processors, 2 system controllers, 3 fan trays, and 8 power supplies. The Cisco NCS 5516 supports up to 16 line cards, 6 switch fabric cards, 2 routing processors, 2 syst...
Read more