FDA issues EUA to convalescent plasma for COVID–19 treatment
The FDA determined that it is reasonable to believe that COVID-19 convalescent plasma may be effective in lessening the severity…
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Regulations/Policies
USPTO grants patent to Tiziana for fully human monoclonal antibody, TZLS-501
The grant of this additional patent on TZLS-501 is of significance for the potential treatment of COVID-19 and other pulmonary…
Quality: How serious are we?
Alok Ghosh, Ex-President - Global Technical Operations, Lupin, informs that with increasing competition and price control, it is…
Bharat Biotech gets green signal from CDSCO to test COVAXIN via skin
Presently, the vaccine is being tested through the intramuscular route
NPPA fixes retail prices of 30 formulations, rejects four applications
Two applications each of Micro Laboratories and Sun Pharma have been deferred by the authority
FDA publishes revised MAPP, Consolidation of ANDAs by the Office of Generic Drugs
This MAPP describes the process for reviewing and approving or denying requests to consolidate previously approved ANDAs submitted…
FDA publishes temporary guidance on manufacturing, supply chain, product inspections during COVID-19
It provides information regarding common questions related to inspections for facilities manufacturing pharma products and sites…
US FDA declines approval for Gilead’s rheumatoid arthritis drug, Filgotinib
The US drug regulator has issued a complete response letter requesting data from the MANTA and MANTA-RAy studies and expressing…
Emergency authorisation for COVID-19 vaccine possible if government decides: ICMR
Normally the final trial takes about six to nine months
NPPA rejects IPA request for upward price revision of five per cent on all drugs
According to DEA analysis concluded that some spike in import prices of certain APIs have been witnessed in the post-COVID-19…
US FDA publishes compliance policy for quantity of samples retained for BA and BE studies
It applies only to the requirements for retention of reserve samples contained in 21 CFR 320.38(c)
Gujarat FDCA to suspend product licenses of over 70 hand sanitisers
In the last three months, it has raided the premises of five firms making hand sanitisers and seized over Rs 40 lakhs of material
D&C Act 1940 should be reframed: Pharma stakeholders
It needs to be updated to suit the industry's present scenario and growth prospects
Pharma industry requests government to delay release of new NLEM list
Industry stakeholders also presented issues related to the NLEM list 2015 and suggested course corrective measures in the upcoming…
CanSino gets COVID-19 vaccine patent from China’s IP regulator
As per reports by state media the patent was issued on August 11
NPPA issues final guidelines to discontinue making medicines under price control
The NPPA website will be uploading the list of applications filed by pharma companies and approved by the competent authority for…
Pharma-telehealth partnerships: Rules of the game
Industry advisors outline the legal aspects that need to be considered and fulfilled as pharma and telehealth players get into…
NPPA sets up Price Monitoring and Resource Unit in Karnataka
Karnataka becomes the 13th state to have a PMRU unit which is now registered as 'Karnataka State Price Monitoring Resources Unit…
DCGI asks drug controllers to prevent sale, distribution of DEG contaminated cough syrup, Cofset
Earlier, the same firms were accused and booked for selling Coldbest cough syrup which contained DEG and caused the death of nine…
FDA finalises guidance, ‘Limited Population Pathway for Antibacterial and Antifungal Drugs’
This guidance is intended to assist sponsors in developing labelling, including prescribing information, patient labelling, and…