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Saturday, January 3, 2026
TopicUSFDA

Topic: USFDA

Paracetamol linked to autism? As Trump warns pregnant women, here’s what science says

President Trump claimed taking Tylenol, simply known as paracetamol, ‘is no good’ & that pregnant women should ‘fight like hell’ to only take it in cases of extreme fever.

Indian doctors more confident about oestrogen therapy for menopause as USFDA may scrap black box warning

USFDA, in a discussion telecast publicly last month, said local oestrogen therapy, such as vaginal cream, is safe & the risks of hormone replacement therapy were overstated.

Top pharma alliance refutes ‘ill-researched’ US study linking Indian generics to higher adverse events

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.

Indian pharmas improved USFDA compliance, but cases of contamination grew 2014-2024—IPA report

The report, released at Global Pharmaceutical Quality Summit in Mumbai, draws comparison of incidences of ‘official action indicated' after USFDA inspections a decade apart.

Govt says no plan to ban heartburn drug ranitidine, carcinogenic impurities within safe limits

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.

In a 1st for US, its FDA approves at-home use of nasal flu vaccine; India’s version yet to gain traction

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.

Import alerts, warning letters, drug recalls — why ‘pharmacy to the world’ is facing US FDA heat

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,...

Using smartwatch to monitor blood glucose level? US FDA strongly advises against it

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.

US FDA approves ‘Xolair’ injection — all about the drug that can help treat severe food allergies

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.

‘Genetic scissors’ — India using same tech to find sickle cell cure as gene therapy approved by US FDA

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.

On Camera

Indian bureaucracy should be given incentives and rewards: MH Mody

Is there a place for a counter-bureaucracy, or a separate and competing bureaucracy to counterbalance the force of the executive’s bureaucracy, asked author MH Mody in 1980.

India’s urban co-op banks are turning the page—crisis to cautious revival, one metric at a time

With bad loans shrinking & capital buffers stronger, urban co-op banks’ new umbrella body NUCFDC is now prioritising rollout of digital transformation.

Greece looking at TATA’s WhAP infantry combat vehicle for army procurement

If deal goes through, Greece will be 2nd foreign country to procure vehicle. Morocco was first; TATA Group has set up manufacturing unit there with minimum 30 percent indigenous content.

A year-end Mea Culpa in National Interest—The Army-Islam combo doesn’t kill democracy

Many of you might think I got something so wrong in National Interest pieces written this year. I might disagree! But some deserve a Mea Culpa. I’d deal with the most recent this week.