As the coronavirus spreads around the globe, unfortunately so do cyber-criminal attacks. Cyber criminals see this as a golden opportunity to capitalize. Hackers leverage the panic, confusion, and misinformation to transmit malware, breach computer networks, set up malicious websites, and launch social engineering attacks. Early on in the coronavirus pandemic, the Cybersecurity and Infrastructure Security […]
On March 10, 2020 FDA announced it was postponing all foreign inspections and on March 18, 2020, only 8 days later, FDA announced it was also stopping all domestic inspections unless mission critical until such time as it is deemed safe for FDA employees and their families as well as the employees of the firms […]
With social distancing, borders closing, people self-quarantining at home, traveler screenings at airports, and people just trying to get home from abroad, perhaps only those contemplating starting or having an ongoing clinical study are thinking about or asking for guidance about what to do with clinical studies, while many of us are simply worried about […]
The FDA issued a guidance today that describes the what, when, and how (as well as other key elements) of its Competitive Generic Therapy (CGT) process. The CGT process was originated with the passage of the Food and Drug Administration Reauthorization Act (FDARA) of 2017. The CGT provisions permit expediting review of ANDAs for products […]
In the normal course of business, firms typically have an expiration date on their product and, when the product reaches its labeled expiration date, the product is not supposed to be used beyond that date. We all know that the expiration date on a product is usually not always a bright line after which being […]
The FDA issued its Fiscal Year (FY) GDUFA Science and Research Report last week (read the full report here and the awarded research contracts and grants here). A review of the innovative scientific focus areas helps those of us in the industry to get a sense of where the FDA is headed in support of […]
The use of contract manufacturers for the production of approved drug products has become more and more commonplace, particularly with the steady increase through the years of virtual pharmaceutical companies, a business model where the majority of the drug development and production work is outsourced to third parties as needed. While the use of a […]
The Q&A document addresses a number of frequently asked questions about the Pre-Launch Activities Importation Request (PLAIR) process, and when you can or cannot use a PLAIR for importing unapproved drug product into the United States. Quite interestingly, there are quite a few answers of “no” to the FAQs, which likely demonstrates that firms have […]
Today’s prepublication of the Federal Register contains the proposed rule for drug importation from Canada. The proposed rule is 172 pages long and outlines the FDA expectations for the safe importation of drug products from Canada. Section 804 Importation Programs (SIPs) provides the basis for each request for importation and provides the importation requirements. The […]
Without much fanfare, on November 11, 2019, OGD approved the first generic vaginal contraceptive ring. Amneal’s approval showed up today on the Drug@FDA, FDA approved drugs list. It is a therapeutic equivalent to Nuvaring by Organon/Merck. Given the ANDA number, it appears that the application was submitted about early to mid-2018, which by all standards […]
