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The approval of such unapproved FDCs compromises patient safety and may lead to adverse drug reactions.(Getty Images/iStockphoto) They have also been asked to review their approval process for ...
all the State and Union Territory drugs controllers are requested to review their approval process for such FDCs and ensure strict compliance of provisions of the Act and Rules. Public health and ...
James Antaki has worked for over 30 years on a device to help infants with holes in their hearts and other defects. Now it’s ...
They have also been asked to review their approval process for such fixed dose combination ... In a communication sent on April 11, Drugs Controller General of India (DCGI) Dr Rajeev Raghuvanshi ...
The Central Drugs Standard Control Organisation (CDSCO) has revised the procedure to issue export No Objection Certificate (NOC) to manufacture unapproved and approved new drugs ... of unapproved and ...
She immigrated from India at age 11 and went on to become ... push the limits of science while navigating the drug-approval process. She told us that when you are doing something innovative ...
MSD’s sotatercept has become the first FDA-approved ... of the disease process in PAH. MSD – known as Merck & Co in the US and Canada – has predicted sales of the drug could reach upwards ...
This indicates a public health crisis characterised by the low availability of drugs ... process. A local Congolese police official told the ENACT organised crime project that much of the illicit ...
Kewalramani, who migrated from India to the United States at the ... to “push the limits of science while navigating the drug-approval process.” Kelly added: “Reshma is the kind of leader ...
Q1 2025 Earnings Conference Call May 8, 2025 8:30 AM ETCompany ParticipantsBill Szablewski - Head of Capital MarketsScott Smith ...
The most common approval process for clinical trials ... wishing to conduct clinical trials in India are required to obtain written permission from the Drug Controller General of India (DCGI).
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