NSD and CME repository cooperate on OTC cross-border transactions
National Settlement Depository (NSD), Russia's central securities depository, a systemically important repository in the Russian market, and CME European Trade Repository Limited (ETR), the ESMA registered and regulated UK-based trade repository that …
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FDA to Revamp Approval Path for OTC Drugs
The agency said it is contemplating certain specific changes that it details in a Federal Register notice to be posted Friday. These include improving the FDA's ability to quickly require new warnings or label changes as safety issues emerge based on …
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A+ Secure Packaging, LLC Earns NSF International Good Manufacturing …
Earning GMP registration from NSF International verifies the A+ Secure Packaging facility meets or exceeds the safety and quality compliance requirements of its clients by demonstrating the proper methods, equipment, and controls for packaging …
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RNA Corporation Launches RNA Pharma LLC a Turnkey OTC products Contract …
RNA Corporation, a US contract manufacturer of ethnic, personal care, skin care, and OTC healthcare products, is proud to announce the launch of a wholly owned subsidiary RNA Pharma LLC, a FDA registered, FDA-cGMP, ISO 9001:2008, and ISO 22716 …
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FDA holds hearing on OTC drug review process; accepting comments until May 12
FDA holds hearing on OTC drug review process; accepting comments until May 12
According to FDA's Federal Register Notice, FDA seeks comments on the strengths and weaknesses of the existing OTC review process, modernization concepts, and modification of or alternatives to the existing OTC review process. FDA apparently believes …
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Two Generic Versions of ADHD Drug Not as Effective: FDA – WebMD
The generic versions were approved by the FDA on the basis that they released the drug in the body over a period of 10 to 12 hours, to achieve the same effect as a three-times-per-day dose of immediate-release methylphenidate hydrochloride. But in some …
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'Boxed Warning' Added to Fibroid Removal Devices
The new warning will let surgeons and patients know that "uterine tissue may contain unsuspected cancer [and] the use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients," the FDA …
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Steer Clear of Cold Meds for Babies, FDA Advises
WEDNESDAY, Nov. 26, 2014 (HealthDay News) — Most babies and young children don't need medicines if they have a cold, the U.S. Food and Drug Administration says. Over-the-counter (OTC) cold and cough medicine should not be given to children …
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