This article is an excerpt from our free white paper, Harmonizing Disparate Quality Systems. Click here to get the full guide, a comprehensive resource for navigating quality issues during mergers and acquisitions.
Success or failure in absorbing a company’s quality system weighs heavily on the due diligence performed by company and department leaders to inform their decisions during the process. While it’s impossible to offer universally-sound advice for a set of tasks so specific to each situation, the steps for integrating a quality system usually follow a familiar pattern:
Regulatory and Quality personnel are deployed to examine 510(k)s, device listings, and labeling to ensure everything is in accordance with regulatory requirements––identifying gaps as they go along. Any gaps that are identified are then addressed as a part of the transition plan.Continue Reading
Earlier this month, the US Food and Drug Administration (FDA) revised its draft guidance detailing the information that must be pre-submitted in order to receive a priority review for an abbreviated new drug application (ANDA).
As a condition of reauthorizing the Generic Drug User Fee Amendments (GDUFA II), the agency has agreed to shorten its review of eligible priority generics by two months if sponsors submit a pre-submission facility correspondence (PFC) at least two months before submitting an ANDA.
During that two-month period, FDA would determine the need for facility inspections in an effort to begin inspection planning earlier in the review process.
Consolidation through mergers, acquisitions, and technology transfers has become an increasingly common trend throughout the pharmaceutical and medical device industries.
In pursuit of emerging therapies and more diverse product offerings, industry heavyweights are crafting alliances and penning new deals while innovative newcomers groom themselves for acquisition.
While last year saw something of a break in the M&A action compared to the two years prior, the market forces driving these decisions continue to apply pressure throughout the industry, leading many to believe the trend will re-accelerate following a period of strategy and future planning.Continue Reading
While many pharmacists see CGMP as having unduly risen the bar of compliance from what they have been accustomed to under SBOP, proper implementation should not be seen as a regulatory burden when compared to the costs of noncompliance––a point made clear in 2012 when improper compounding at the New England Compounding Pharmacy sparked an outbreak of fungal meningitis which resulted in 64 deaths, hundreds of injuries, and serious criminal charges.Continue Reading
On October 31, 2017, The U.S. Food and Drug Administration (FDA) announced it will take the "unprecedented step" of recognizing drug manufacturing facility inspections around the world conducted by eight European agencies, in an effort to reduce duplicative oversight through greater collaboration with the EU member states.
FDA has agreed to rely on GMP inspection data gathered by drug regulators in Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom.
This new international recognition by FDA comes in response to similar steps taken by the European Commission, which in June of 2017 confirmed that FDA is capable of conducting GMP inspections equivalent to those conducted in the EU.Continue Reading
In 2015 and 2016, there were over 150 major medical device company acquisitions and mergers, and that trend has only accelerated in 2017. These events often bring important questions regarding quality that can have far-reaching consequences if not addressed thoroughly by both department and company leadership.
We've compiled insights from experts with firsthand experience helping device manufacturers make informed decisions when integrating quality systems and performing the due diligence necessary to ensure compliance in both the short and long term.Continue Reading