The Institute for Clinical and Economic Review (ICER) and the Peterson Health Technology Institute (PHTI) have partnered to assess digital health technologies (DHTs) against the standards that devicemakers should meet…
The FDA issued a complete response letter (CRL) to Coherus Biosciences on its BLA for a biosimilar of Neulasta (pegfilgrastim) solely due to an ongoing review of inspection findings at…
With the approval of seven adalimumab biosimilars since January, AbbVie may have lost the keys to its Humira kingdom, and with it, up to $8 billion in sales this year…
Nearly 96 percent of pharmacy technicians recently surveyed said they are facing drug shortages, primarily for chemotherapy drugs, medicines for ADHD, GLP-1 agonists for weight loss and diabetes, and local…
The frequent electronic exchange of health data through wireless, internet and networks along with the cybersecurity threats and vulnerabilities is driver for an FDA final guidance making recommendations for cybersecurity…
This European Edition of Quick Notes includes guidelines from WHO for pharmaceutical quality control laboratories, UK launch of the Innovative Devices Access Pathway pilot, European Commission (EC) unannounced antitrust inspections…
The FDA has deemed Hamilton Ventilators’ recall of its C1, C2, C3, T1 ventilators as class I, as the company has received reports of software issues that may cause the…
The FDA has no obligation to educate companies about what is and isn’t fair game during an inspection and there is no equivalent of a “Miranda warning” that cops must…
Eli Lilly and Boehringer Ingelheim have secured another FDA approval for blockbuster diabetes drug Jardiance (empagliflozin), announcing that the agency has OK’d the drug for treating adults with chronic kidney…
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on laws and regulations that could impact your business. Source: Drug Industry Daily