Outsourcedpharma.com
FDA Issues Second DSCSA Warning Letter — What Does This Mean
WEBBy Madeleine Giaquinto, J.D., Greenleaf Health. In June 2023, with a dwindling number of months before final requirements of the Drug Supply Chain Security Act (DSCSA) must be met, impacted drug supply chain stakeholders received some additional insight into the FDA’s potential DSCSA enforcement approach through a …
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URL: https://www.outsourcedpharma.com/doc/fda-issues-second-dscsa-warning-letter-what-does-this-mean-0001
How Is The Future Of Nuclear Medicine Evolving
WEBNuclear medicine, with its fusion of medical imaging and therapeutic techniques, is reshaping the way diseases are diagnosed, treated, and managed. From detecting early signs of cancer to pinpointing neurological disorders with exceptional accuracy, nuclear medicine is propelling healthcare into a new era of precision and …
4 Concepts For Supply Chains And Your Good Supply Practices …
WEBBy Louis Garguilo, Chief Editor, Outsourced Pharma. The full “Good Supply Practices for the 21st Century” research report is out – 150-plus pages of supply-chain guidance. Many of us have anticipated for years this grand finale, spearheaded by Xavier Health.. Back in 2015, I wrote this of what became a 6-year process to get to the bottom of how the …
Your Medical Device Software Will Need Updated
WEBProactive Steps Toward Secure Medical Device Software Updates. A secure medical device update plan encompasses several elements, including these steps medical device manufacturers should be taking already: Start with secure design — First, make sure you are following up-to-date cybersecurity guidelines as you develop your device.
Phlow Corporation Awarded $354M HHS/ASPR/BARDA Contract …
WEBMove Strengthens America's Supply Chain and Supports COVID-19 Response. Richmond, VA /PRNewswire/ - Phlow, a U.S.-based, public benefit drug manufacturing corporation, has received federal government funding of $354 million for advanced manufacturing of America's most essential medicines at risk of shortage, …
The Business Case for Healthcare Compliance Programs for …
WEB<p>For emerging drug and medical device companies on a tight budget, an effective healthcare compliance program can actually save precious resources by establishing better oversight, controls, and monitoring of the company’s quality, R&D, clinical, and market access activities. Such a program should be …
Quintiles Acquires Encore Health Resources
WEBBy Marcus Johnson. Quintiles has announced that it has entered in an agreement to acquire Encore Health Resources, which is a health information and analytics company that provides technology services to healthcare providers.Encore helps its clients through the use of analytics and big data, helping clients through strategy, …
Catalent Invests Over $27M To Commercialize Zydis® Ultra, A …
WEBCatalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today announced that it is to invest more than $27 million to commercialize its next-generation oral disintegrating tablet (ODT) technology, Zydis® Ultra.
Sanofi US Launches Second Innovation Challenge Collaborate …
WEBDeveloping approaches for involving patients in drug development. Bridgewater, NJ /PRNewswire/ - Today, Sanofi US launched its second Partners in Patient Health (PiPH) Innovation Challenge: Collaborate | Innovate, which will award $100,000 to …
Tools And Best Practices For Trending Environmental Monitoring …
WEB<p>Environmental monitoring (EM) trending is an essential component of the EM program to evaluate the overall health of the facility in terms of microbial control. Part 1 of this series looked at the regulations and guidelines around EM. This article discusses tools and best practices for using the trends to ensure establishment of an …
Exelixis And Catalent Enter Into Collaboration, License, And …
WEBExelixis, Inc. and Catalent today announced a partnership under which Catalent's Redwood Bioscience subsidiary will develop multiple antibody-drug conjugates (ADCs) for Exelixis using Catalent's proprietary SMARTag site-specific bioconjugation technology.
Signant Health, formerly CRF Bracket
WEBSignant Health, formerly CRF Bracket. Who Is Signant Health? The best technology succeeds in the background. Signant Health provides solutions that simplify every step of the patient journey to make it easier for people to participate in, and for sites and study teams to run, clinical trials. Signant unites eCOA, eConsent, Patient …
The Challenge And Promise Of Pediatric Device Innovation
WEBBy Matthew R. Maltese, The Pennsylvania Pediatric Medical Device Consortium, and Daniel Henrich, Archimedic. As a society, we seem to regard the lives of children as more innocent, precious, and worthy of protection than those of adults.
ABL Enters Seven-Year Multimillion Dollar Contract With NIH For
WEBAdvanced BioScience Laboratories (ABL), a global Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) serving the US Government and biopharmaceutical industry, today announces it was awarded an Indefinite Delivery, Indefinite Quantity (IDIQ) contract by the National …
Risk Factors To Consider When Selecting Medical Devices For
WEB<p data-pm-slice="1 1 []">While risks can be reduced to a residual level, it is not possible to eliminate a risk entirely. Such risks are foremost about injury to the patient and to the user. Other associated risks may be to the environment or with any data collected. It is incumbent upon the purchaser or distributor to assess a new supplier of …
Amneal Pharmaceuticals Receives FDA Approval For Generic …
WEBBRIDGEWATER, N.J.--(BUSINESS WIRE)--Amneal Pharmaceuticals, LLC, the 7 th largest generic drug manufacturer in the U.S. market, has received U.S. FDA approval for one of the first generic versions of Suboxone ® sublingual tablets for maintenance treatment of opioid drug dependence.Generic buprenorphine hydrochloride (HCl) and naloxone HCl …
Catalent Signs Development Agreement With Ennaid Therapeutics …
WEBCatalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced a collaboration with Ennaid Therapeutics to develop an oral, antiviral treatment targeted at COVID-19.
AbbVie To Acquire Allergan In Transformative Move For Both …
WEB<p>AbbVie Inc. (NYSE: ABBV) and Allergan plc (NYSE: AGN) announced that the companies have entered into a definitive transaction agreement under which AbbVie will acquire Allergan in a cash and stock transaction for a transaction equity value of approximately $63 billion, based on the closing price of AbbVie's common stock of …
Introduction To The New ASTM E3418, <em>Standard Practice For
WEB<p>The ASTM E55 Cleaning Team has developed and balloted a new standard practice for calculating safe and scientifically justifiable limits for residues found after cleaning processes. This is the first comprehensive guide to setting limits for use in cleaning validation that includes all types of chemical residues, bioburden residues, …
Catalent Completes Accucaps Acquisition To Expand Softgel …
WEBCatalent, Inc. (Catalent), the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, recently announced that it has completed the acquisition of Accucaps Industries Limited (Accucaps), the Canada-based developer and manufacturer of Over-the-Counter (OTC), high …
Catalent Expands OptiMelt Hot Melt Extrusion Capabilities At …
WEBCatalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, recently announced that it has invested a further $5M at the company’s Somerset, New Jersey, drug development center of excellence to expand its OptiMelt hot melt extrusion (HME) …
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