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Aldeyra Therapeutics on Monday announced receipt of an FDA complete response letter (CRL) for the NDA of reproxalap, for the treatment of dry eye disease, asking the company to conduct an additional trial to show the efficacy of the drug. Read More
Sponsors of drugs being developed to treat or prevent COVID-19 should consider the importance of enrolling older adults, including those 75 and older, in drug trials and even consider running trials in nursing homes and other facilities that care for the elderly, the agency advises in a straight-to-final guidance. Read More
A new eligibility checker for the UK’s Medicines and Healthcare products Regulatory Agency’s (MHRA) International Recognition Procedure (IRP) has gone live, enabling drugmakers to determine if their drug will be eligible to use other countries’ regulatory approvals to speed MHRA acceptance. Read More
The FDA has withdrawn from the Global Harmonization Working Party (GHWP) and will focus its efforts to ensure alignment of medical device international harmonization by primarily working with the International Medical Device Regulators Forum (IMDRF). Read More
The lot size doesn’t really matter when it comes to choosing a sample size for a pharmaceutical or medical device, says sampling expert Steven Walfish. Read More
Nearly half of rare oncology drug approvals include postmarketing requirements (PMR) for drug-drug interactions (DDI), a particular concern for cancer patients who are frequently being treated for co-morbidities and palliative care. Read More
The FTC has filed an amicus brief amid the ongoing dispute between Viatris’ Mylan and Sanofi over the latter’s patents for Lantus insulin, assailing the use of improperly listed Orange Book patents to delay generic competition. Read More
Reorganization of two of the FDA’s larger offices in 2024 will bring about changes in how the agency handles inspections and drug assessments. Read More
When the rare disease patient community was seeking to have the FDA pay more focused attention to orphan drugs, they asked Janet Woodcock for support. She established within CDER a new office dedicated to orphan drugs and rare diseases. Read More