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Pandemics. War. Political upheaval. Severe weather. Availability of energy supplies. Any of these can kink up the supply chain, making it difficult (and sometimes impossible) to get drugs to the patients who need them, said Dionne Dosa, executive director of CMC Procurement for Moderna. Read More
Celgene and Bristol Myers Squibb (BMS) have used a pattern of unlawful patents to extend a monopoly in the market for Pomalyst (pomalidomide), a blockbuster drug used in the treatment of multiple myeloma, according to a lawsuit filed by Blue Cross and Blue Shield of Louisiana (BCBS). Read More
The FDA has released a draft guidance on how it intends to determine whether sponsor-provided prescription drug software output should be treated as FDA-required labeling or promotional labeling and how, or if, the corresponding software function should be described in the prescribing information (PI). Read More
Focusing on fostering a culture of quality in a drug manufacturing company seems obvious today — a given. But that wasn't always the case, explained industry veteran Sue Schniepp, a distinguished fellow at the consulting firm Regulatory Compliance Associates. Read More
The FDA has offered greater direction on demonstrating substantial evidence of effectiveness for drugs and biologics, publishing draft guidance on whether a single trial plus confirmatory evidence will suffice for a development program. Read More
GSK’s Ojjaara (momelotinib), the first and only treatment for myelofibrosis patients with anemia regardless of prior myelofibrosis therapy, received FDA approval on Friday. 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
The FDA released two draft guidances for biosimilar manufacturers — one on labeling that focuses on prescribing information and the other on the FDA’s licensure requirements. Read More