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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 when generating early studies for their products. Read More
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 a third-party filler, the company said. Read More
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 alone, but for generics makers, surpassing AbbVie will require an uphill battle fought on several fronts — patents, pricing, patients and prescribers. Read More
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 anesthetics such as lidocaine, while Pfizer reopens its NC plant — but only partially. Read More
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 information to be submitted with premarket applications to CDRH and CBER. Read More
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 at a medical device company and an open letter to the EC about MDR and IVDR. Read More
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 give when detaining individuals, says inspections expert David Chesney, principal of DL Chesney Consulting. Read More
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 disease. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on laws and regulations that could impact your business. Read More