Success in developing a drug product, medical device, or drug substance requires navigating the tradeoffs and decisions of today's complex global regulatory realm. Some of the most common questions about compliance concern dealing with the FDA 483 list of inspection observations, warning letters, and consent decrees following FDA regulatory action. [Online name] posed some important questions about warning letter responses and remediation — and other important regulatory issues — to Richard Aleman, VP of regulatory compliance at Pharmatech Associates. Aleman has an insider’s view on these issues, having spent 28 years at the FDA in both the field and headquarters organizations, specializing in biopharmaceuticals, drugs, and medical devices.
During my visit to Thailand, I was privy, not only to the particularly innovative research goals being pursued, but also to a number of challenges the country has recognized and hopes to address within the next few years to encourage a stronger, more diverse industry.
A few weeks ago, I was invited by the Thailand Board of Investment to attend a media trip to learn about the country’s budding life sciences industry. Entering Thailand, a country in which the government is pushing more investment and education in the sciences, was even more striking and meaningful to me given the current scientific climate in the U.S.
In the spirit of this list-making season, I compiled what I thought were the five most important biosimilar-related triumphs in the past year. Many of these events were widely covered by the media and will play an influential role in how the biosimilar industry unfolds through 2017 and beyond.
Pfizer's Bernie Huyghe and ADC Therapeutics' Michael Mulkerrin get bushwhacked with this question in a public forum. Their open replies will help each one of you to your own personal assessment. Be prepared for some soul searching.
Relocating an organization as large as the EMA, which employs upwards of 1,000 people in London, will be no easy feat. As such, IDA Ireland, an agency that supports companies in Ireland and promotes foreign direct investments in the country, is working to compile information on why Ireland would be a good location for the EMA.
Success in developing a drug product, medical device, or drug substance requires navigating the tradeoffs and decisions of today's complex global regulatory realm. Some of the most common questions about compliance concern dealing with the FDA 483 list of inspection observations, warning letters, and consent decrees following FDA regulatory action. [Online name] posed some important questions about warning letter responses and remediation — and other important regulatory issues — to Richard Aleman, VP of regulatory compliance at Pharmatech Associates. Aleman has an insider’s view on these issues, having spent 28 years at the FDA in both the field and headquarters organizations, specializing in biopharmaceuticals, drugs, and medical devices.
While other industries have learned from the principles of quality and statistical control methodology, (bio)pharma has been slow on the uptake. This article proposes tactic designs that utilize collaboration tools to facilitate Kaizen/continuous improvement in quality management systems (QMSs).
Integrated delivery networks (IDNs) were among the earliest adopters of Medicare accountable care organization (ACO) programs. The Centers for Medicare and Medicaid Services (CMS) releases results specific to these programs on an annual basis, creating opportunities for new drug development.
The European Union’s (EU) Falsified Medicines (FMD) Directive 2011/62/EU amends Directive 2001/83/EC to safeguard public health by protecting the pharmaceutical supply chain from infiltration by falsified (or counterfeit) medicines. It also introduces new rules to more rigorously regulate the supply chain.
It has never been clear whether visual inspection is reliable since it has never actually been validated. If it can be validated, then the use of this technique for release of equipment would be justified and might even be used in place of traditional swab methods, which take substantial amounts of time and resources to develop, validate, and perform.
Where health is concerned, trust is central to the healing process. In addition to the medical knowledge of the physicians who treat us, and confidence in our own body's defences, above all we trust in the efficacy of drugs.
To ensure quality of pharmaceutical raw materials and products, it is very important to monitor specific factors throughout supply chain. In cold chains, temperature is closely controlled and monitored.
Even with forecasting and building out a sizeable buffer inventory, clinical sites may still not always have the appropriate kits on hand to dispense to patients. Why?
The humidity sensor is a small capacitor consisting of a hygroscopic dielectric material placed between a pair of electrodes.
Six tips on how to coordinate team activities or collaborate authoring and reviewing content when working with R&D professionals
The move from sterility testing within LAF safety cabinets to those in aseptic isolators has resulted in a marked decrease in false positives.
