As the divorce date approaches for the U.K. and the EU, one would be forgiven for thinking there would be a plan in place to deal with an event that will have such a profound global impact on the pharma industry. However, manufacturers have to prepare for any possibly scenario, while continuing to wait for clarity.
Finding a contract laboratory to fit the needs of your product is often challenging. Especially in the clinical and preclinical space, laboratory support is critical to presenting a foundation to the agency that your product is of the right quality and safety, and the basis of this before validation batches have been made depends wholly on the quality controls in place.
CMS has announced a new payment model that seeks to reduce out-of-pocket costs for patients. This payment model arises out of the Trump administration’s American Patients First Blueprint that was released earlier this spring. CMS is providing this notice of its proposed payment model via an Advance Notice of Proposed Rulemaking (ANPRM), meaning a formal proposed rule will be introduced in the near future. Comments close on this ANPRM on Dec. 31, 2018.
Outsourced GMP-regulated activities have clear requirements, including the use of quality-technical agreements (QTAs). The principles described in this article may be applied to both commercial and precommercial stages of the product life cycle and to any relationship with suppliers that provide outsourced GMP-regulated activities.
Let's assume you have your pre-IND ducks in a row. Now you're ready to embark on preparing and submitting the IND application to the FDA, which, if approved, will allow you to test your drug in humans for the first time.
Breathing is an involuntary reflex action and one of the most basic yet important functions that the body performs. However, for millions who suffer from chronic lung problems and respiratory disease, a single breath is never taken for granted. Certain respiratory diseases are the leading cause of death in the US and include chronic lung problems, such as asthma, bronchitis, and emphysema. In addition, heart attack and accident victims, premature infants, and people with cystic fibrosis and lung cancer suffer from respiratory problems.
CEO of Rolex sounds like a pretty desirable job title and it might have been fun a year ago, when Dufour took the job. Back then, rumors of the Apple Watch were just rumors, and the idea of a tiny computer on the back of your wrist seemed a touch ridiculous.
If the activity happening in state legislatures across the country heralds change at the federal level — and it likely does — pharmaceutical manufacturers ought to buckle their seatbelts.
The concept of optionality is key to staying flexible in biomanufacturing by keeping your options open and having multiple pathways to take while navigating through this highly uncertain environment.
The supply chain problems highlighted most frequently include lack of coordination, inventory management, absent demand information, human resource dependency, order management, shortage avoidance, expiration, warehouse management, temperature control, and shipment visibility.
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