WEBFeb 22, 2021 · The US Active Pharmaceutical Ingredient Infrastructure: The current state and considerations to increase US Healthcare Security “Keeping the Nation’s drug supply chain secure, robust, and resilient is essential for the national security and economic prosperity of the United States1.” I. Summary
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Good Documentation: More Than Entering Data | 2014-08-13
WEBAug 13, 2014 · Good Documentation Practices are guided by five standards. These standards consist of truth, accuracy, completeness, legibility, and timeliness. Truth: This standard maintains that the person who completed the process or performed the task actually did the work—and completed the appropriate documentation. No signature stamps are to be used ...
FDA Approves ClorDiSys to Sterilize Devices with Chlorine
WEBThe FDA has granted approval for ClorDiSys to provide contract sterilization for medical devices using chlorine dioxide gas, a chemical that has some advantages over the industry standard ethylene oxide. Chlorine dioxide gas is non-carcinogenic and is able to sterilize devices that contain embedded batteries, as well as complex devices within bulk packaging, the Branchburg, N.J. firm said.
FDA Warns Internet Pharmacy Against Selling Drugs That
WEBJan 6, 2023 · The FDA sent a warning letter to Global Pharmacy Plus, an internet pharmacy, concerning the company’s marketing of generic versions of the immunosuppressant drugs mycophenolate mofetil and tacrolimus, both of which carry Black Box warnings and must only be distributed under an approved Risk Evaluation and Mitigation Strategy (REMS).
Federal Judge Tells FDA it Must Make Public 55,000 Pages a
WEBJan 7, 2022 · A federal judge in Texas has ruled that the FDA must by the end of this month make public 12,000 pages of the data it used to make decisions about approvals for Pfizer/BioNTech’s COVID-19 vaccine — and then release 55,000 pages every 30 days after that until all 450,000 requested pages are public. The request for FDA’s Pfizer/BioNTech data flows from an August 2021 Freedom of Information ...
WEB4 1 Postmarket Surveillance Under 2 Section 522 of the Federal Food, Drug, 3 . and Cosmetic Act 4 . 5 . Draft Guidance for Industry and 6 . Food and Drug Administration Staff 7 . 8 . This draft guidance, when finalized, will represent the …
FDA Clears SoftWave’s Shockwave Treatment | 2021-05-20
WEBMay 20, 2021. SoftWave Tissue Regeneration Technologies has received 510 (k) clearance from the FDA for OrthGold 100, a device for temporarily increasing blood circulation, relieving minor aches and pains, and activating connective tissue. The extracorporeal shockwave device is used by physicians and healthcare professionals to provide relief ...
WEBourt of Justice of the European Union can give binding interpretations of Union law.IntroductionThis guidance document concerns performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices (IVDs) in. the context of conformity assessment under either Directive 98/79/EC or Regulation (EU) 2017/746. It covers devices for detection or ...
Longeviti Gets FDA’s 510(k) Clearance for Its Implantable ClearFit ...
WEBNov 22, 2021 · Baltimore, Md.-based Longeviti Neuro Solutions has received the FDA’s 510(k) clearance for its ClearFit OTS (off-the-shelf) implantable prosthetics for correcting cranium bone voids. The cranial implant, which is designed to help surgeons address urgent reconstructive clinical needs, is made of polymethyl-methacrylate, a sonolucent, biocompatible material that has been used in clinics for ...
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