Pharma News

The Union Health Ministry decide  for renaming the country's drug regulator CDSCO in line with its expanded roles. In a public notice issued on 6.9.2018, the Central Drugs Standard Control Organisation(CDSCO) said its name was given keeping its role when it was created, but the present nomenclature was not reflecting its roles and responsibilities.

Advancing better nutrition is one of my top priorities and implementing the update to the iconic Nutrition Facts label — the first overhaul in 20 years — is a key part of that commitment.

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The practice of compounding medicines can provide important public health opportunities. The FDA’s compounding program – including implementation of the compounding provisions of the law – is a priority for the agency.

Over the past 25 years, globalization of drug manufacturing has prompted the FDA to change its regulatory landscape. The shift to overseas production of U.S. goods, including some drugs and their components, predominantly occurred in the early 2000s. It added new complexities to our supply chain. This required the FDA to take different steps to ensure that our drug manufacturing surveillance program kept pace with the evolving landscape and make sure consumers continued to receive safe and effective drug products.

Four new grants will help to move scientific discoveries and technologies out of the lab and into commercial products that improve patient care and enhance human health. Awards for Regional Technology Transfer Accelerator Hubs for Institutional Development Award (IDeA) states will total almost $2 million in the first year and potentially more than $13 million over three years, pending the availability of funds.

The countries of WHO’s Eastern Mediterranean Region signed a UHC2030 Global Compact during the “Ministerial meeting on the road towards universal health coverage” taking place in Salalah, Oman, from 3 to 5 September 2018. Ministers of health and heads of delegations collectively approved the landmark document, making the Region the first among WHO’s 6 regions to do so.

The U.S. Food and Drug Administration is warning consumers and health care professionals about a voluntary recall of one lot of Montelukast Sodium Tablets – lot number MON17384, expiration 12/31/2019 – by Camber Pharmaceuticals, Inc., Piscataway, N.J. Sealed bottles labeled as montelukast sodium tablets, 10 milligram, 30-count bottle from Camber were found to instead contain 90 tablets of Losartan Potassium Tablets, 50 mg.

“India has fast-tracked many initiatives aimed at achieving all the core tenets of Universal Health Coverage i.e, strengthening health systems, improving access to free medicines & diagnostics and reducing catastrophic healthcare spending.” This was stated by Shri J P Nadda, Union Minister of Health and Family Welfare at the inauguration of  the ‘71st Session of the WHO Regional Committee for South-East Asia.

U.S. Food and Drug Administration announced its new export certification program for certain FDA-regulated food products and fees it will assess for issuing new export certifications to U.S.-based manufacturers or exporters of these products. Export certification under the Federal Food, Drug & Cosmetic Act (FD&C Act) provides U.S. exporters another tool to facilitate exports to countries that import food products from the U.S.

This guidance provides recommendations to industry on the development of a shared system risk evaluation and mitigation strategy (REMS) for multiple prescription drug (including biological) products.