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To List or Not to List; That is the Question – The FTC Signals the Potential for Greater Scrutiny of Patent Information Submissions to FDA

FDA Law

The six-page statement explains that “Brand drug manufacturers may be harming generic competition through the improper listing of patents in the. 5429, the “ Medication Affordability and Patent Integrity Act.” But it is not always clear which types of patents are eligible for listing in the Orange Book.

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Arsenicum album for Kerala school students: a bogus prophylaxis

Tiny Physician

Indian Medical Association (IMA) Kerala wing criticized the minister at that time as the medicine lacked scientific evidence (2). It is worth noting that Covaxin, our indigenously developed vaccine manufactured by Bharat Biotech, is on the verge of getting approval in the pediatric age group as well (6). Dipankar et.

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FDA Approves First State Drug Importation Program Under 20-Year-Old Statute, But High Hurdles Remain

FDA Law

After its enactment in 2003, successive administrations thwarted its implementation by declining to certify to Congress that importation will pose no additional risk to public health and safety and will result in a significant reduction in cost to American consumers, as the statute requires. See 21 C.F.R. 251.5; § 251.6(c).