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In a final guidance published by CBER and CDRH, the FDA provides updated standards for premarket notification (510(k)) submissions by electronic format and establishes Oct. 1 as the start date for use of the revised standard. Read More
A recent study of cardiac patients using a digital health solution found no long term impact on physical activity, demonstrating the difficulty of establishing the value of digital health technology. Read More
Humira’s biosimilar competitors have overcome the approval and patent fight process, only to run straight into what may be an even bigger challenge: getting the drugs past pharmacy benefits manager (PBM) gatekeepers and earning the trust of clinicians and patients. Read More
Eli Lilly and Point Biopharma Global have announced that Lilly will pay $1.4 billion to acquire Point, a radiopharmaceutical company with a pipeline of clinical and preclinical-stage radioligand therapies in development for the treatment of cancer. Read More
The FDA has issued a revision to its Manual of Policies and Procedures (MAPP) describing how the Office of Generic Drugs will track and respond to ANDA suitability petitions, consistent with the commitments made in the GDUFA III commitment letter. Read More
Citing deficiencies in the Chemistry, Manufacturing, and Controls (CMC) processes, FDA handed Swiss drugmaker Galderma a complete response letter for RelabotulinumtoxinA, the company’s cosmetic neurotoxin intended to treat frown lines and crow’s feet. Read More
CBER has issued warning letters to manufacturers for product sterility, failure to seek approval for drug and/or biologic products, inadequate labeling and GMP violations. Read More
Invitae’s in vitro diagnostic test that uses a blood sample to help detect hundreds of genetic variants associated with an elevated risk of developing certain cancers has received de novo marketing authorization by the FDA. Read More
Eli Lilly announced on Monday that it has received its second FDA complete response letter (CRL) related to findings from an inspection of the third-party contract manufacturing organization, this time for production of the company’s eczema drug, Lebrikizumab. Read More
Only about half of drug manufacturers have systems that comply with what regulatory bodies want to see in Quality Risk Management (QRM) — though the FDA and the International Council for Harmonisation (ICH) both released updated guidance on the topic earlier this year, said Beth Slater, industry veteran and founder and president of consulting firm Quality Confidential. 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
Citing a continued dramatic growth in the use of laboratory-developed tests (LDT) over the past two decades, the FDA Friday announced a proposed rule that would bring the tests under the agency’s purview, trying a new route to put to rest the decades-long debate over who should provide oversight. Read More