Pharmaceutical giant AbbVie (NYSE:ABBV) has won U.S. antitrust approval for its purchase of Allergan (NYSE:AGN) for $63 billion in cash and stock. The purchase is seen as a hedge against the impending expiration of U.S. patents on AbbVie’s blockbuster drug, Humira. North Chicago-based AbbVie announced the deal in June 2019, but ran up against U.S. Federal Trade Commission…
Next COVID-19 device shortage? ‘Smart’ infusion pumps
Severely ill COVID-19 patients may need multiple medications delivered by infusion pumps. Manufacturers and hospitals are planning on how to avoid shortages of these pumps and the associated tubing. You’ve likely seen the videos of ICU hallways lined with medical devices that would normally be in patient rooms. Among them are machines that are ubiquitous…
Drug deactivation system helps N.J. pharmacies comply with new anti-overdose law
Verde Environmental Technologies announced that it launched four new retail products with its Deterra system in compliance with New Jersey’s “Charlie’s Law” that requires every pharmacy practice site in the state to provide effective options for consumers to dispose of unused, unwanted or expired medications. The law requires pharmacies to carry effective drug disposal methods…
Hurry Up and Wait: Brexit from a Regulatory Point of View
You Brexit, You Buy It – Europe and the New Regulatory – Part 1 of 2 By Lynn Hansen, Director of Clinical and Regulatory Affairs, Pharmatech Associates With Brexit looming, questions and concerns hover like a grey cloud over the UK pharmaceutical industry. Industry insiders and colleagues in London found that the confusion surrounding what…
Hurry Up and Wait: Brexit from a Regulatory Point of View – Part 2
You Brexit, You Buy It – Europe and the New Regulatory – Part 2 By Lynn Hansen, Director of Clinical and Regulatory Affairs, Pharmatech Associates In Brexit Part 1, I expressed my Brexit thoughts as Theresa May was providing a tearful resignation and now the United Kingdom has the return of an energetic Boris Johnson,…
Jump into cGMP: An FDA Roadmap to Manufacturing Tissue-based Products
Companies currently in the tissue-based regenerative medicine business need to understand and comply with the FDA’s expectations for human cells, tissues and cellular and tissue-based product (HCT/P) under development in the next two years. HCT/P pertains to products containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient. If we are to jump…
Regulatory Experience Plays into New Regulatory Affairs Certifications for 2019
With new exams introduced this year, the Regulatory Affairs Certification (RAC) program has seen major changes since the beginning of 2019, as announced at the Regulatory Affairs Professional Society (RAPS) Regulatory Annual Convergence meeting in October 2018. There are two new Regulatory Affairs Certifications with the associated exams for RAC (Drugs) and RAC (Devices). These…
ERP Verification and Validation in a Highly Regulated Environment
The U.S. Food and Drug Administration has created a complex regulatory regimen to ensure the safety of products offered to consumers. It also helps mitigate the risk for manufacturers by mandating that they adhere to these stringent requirements. Making the Right Choice The enterprise software selected for manufacturing medical devices and pharmaceutical products is of…
Pharma Execs Face the Feds
The leaders of seven major pharmaceutical companies have been called to testify before the Senate Finance Committee, on the topic of drug prices. The committee is led by Senators Chuck Grassley of Iowa and Ron Wyden of Oregon, who argue that prescription drug costs have climbed too high and the rate at which prices are…
