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.

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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.

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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. 

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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.

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On October 24, FDA finalized two guidances offering insight into when a new 510(k) is required following changes made to medical devices or the software powering them.

The drafts of these two guidances were released in the fall of 2016, five years after FDA's initial attempt at replacing its 1997 guidance outlining 510(k) changes. Deciding When to Submit a 510(k) for a Change to an Existing Device (“2016 Device Change Guidance”) revised FDA's 1997 guidance of the same name. The other, Deciding When to Submit a 510(k) for a Software Change to an Existing Device (“2016 Software Device Change Guidance”), presents guidelines for particular software changes.

Regulators have stated that the final versions of the guidances have been updated for clarity and to ensure they are interpreted consistently by agency staff and device manufacturers.

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