Drug sponsors should assess the safety of non-genotoxic impurities (NGIs) in chemically synthesized drugs on a case-by-case basis, the EMA’s Committee for Medicinal Products for Human Use suggests in a draft reflection paper released for stakeholder comment.
Source: International Pharmaceutical Regulatory Monitor
Category Archives: International Pharmaceutical Regulatory Monitor
Pfizer’s appeal for a second patent on Lyrica (pregabalin) has been denied by the UK’s highest court, ending the pharma giant’s long-running fight against drug companies marketing generic versions of its blockbuster pain treatment.
Source: International Pharmaceutical Regulatory Monitor
The FDA released final guidance for sponsors of fixed-combination hypertension drugs, with several clarifications of the draft document.
Source: International Pharmaceutical Regulatory Monitor
The FDA hit back at Teva’s lawsuit accusing the agency of changing its policy on granting 180-day exclusivity for generics — arguing that the company’s attempt to block exclusivity for competing Restasis (cyclosporine) generics was “built atop a tottering tower of conjecture.”
Source: International Pharmaceutical Regulatory Monitor
FDA Commissioner Scott Gottlieb said the agency is committed to ensuring “timely completion” of post-marketing studies by drug sponsors in a statement about the agency’s latest report on the status of reviews.
Source: International Pharmaceutical Regulatory Monitor
The FDA is seeking public comment on how it should regulate prescription drug software apps and says some apps might have to be regulated as a device — such as a software program that uses advanced algorithms to scan skin lesions for evidence of cancer.
Source: International Pharmaceutical Regulatory Monitor
Commissioner Scott Gottlieb unveiled a redesigned FDA website on expanded access to clinical trials on Nov. 8 and said the agency is “deeply committed” to helping critically ill patients with no other treatment options to join trials.
Source: International Pharmaceutical Regulatory Monitor
International regulators need to take action to reverse the steep decline in research and development for antibiotics, according to the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).
Source: International Pharmaceutical Regulatory Monitor
Some nations may be consuming too many antibiotics that the World Health Organization has determined must be reserved for emergencies to limit antibiotic resistance.
Source: International Pharmaceutical Regulatory Monitor
The state of Kentucky filed a lawsuit against Teva, alleging the drugmaker’s off-label promotion of two drugs for cancer pain has exacerbated the opioid epidemic.
Source: International Pharmaceutical Regulatory Monitor