Indian Pharmaceutical Alliance says the study relies on FDA Adverse Event Reporting System data, which captures link between drugs & adverse events, but does not prove causation.
The report, released at Global Pharmaceutical Quality Summit in Mumbai, draws comparison of incidences of ‘official action indicated' after USFDA inspections a decade apart.
In 2019, evidence showed that an impurity in drug degrades over time to form probable carcinogenic compound. Ranitidine is sold as heartburn medicine under names Rantac, Aciloc & Zinetac.
US's FluMist can now be administered by a healthcare provider or by recipient or caregiver aged 18 or above. India's Nasovac S4 faces hurdles like cost, availability & low acceptance.
New Delhi: On 18 April, Mumbai-headquartered Marksans Pharma, a drugmaker that supplies generic drugs in over 50 countries around the world, received form 483,...
US regulator says devices that claim to monitor blood glucose levels in real time without piercing skin may show inaccurate & misleading results and pose risks for people with diabetes.
The drug, which blocks allergic reactions to more than one type of food, is the first FDA-approved medication to reduce risk of anaphylaxis from accidental exposure to multiple foods.
FDA-approved Casgevy & Lyfgenia made from patients’ blood stem cells which are modified and given back as single-dose infusion. India ‘in preclinical stage’ of trial of similar therapy.
VLA1553, commercially known as Ixchiq, has received USFDA clearance and will be launched in India — which has seen high number of chikungunya cases — after ‘regulatory talks with DCGI’.
FDA is scheduled to review gene therapies from two American companies — Vertex Pharmaceuticals & Bluebird Bio Inc. If approved, therapies could mean a breakthrough for curing SCD.
One has to be incredibly credulous to buy BJP spin masters’ argument that the government got rid of Vice President Jagdeep Dhankhar for harmonious relationship with the judiciary.
In the latest budget, the FDI limit was increased to 100 percent, but most foreign companies are not buying such large stakes in the Indian insurance sector.
Modi government had also made numerous efforts to establish peace with Pakistan but has now adopted a different path, militarily, to establish peace, adds defence minister.
As Narendra Modi becomes India’s second-longest consecutively serving Prime Minister, we look at how he compares with Indira Gandhi across four key dimensions.
COMMENTS