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Dr. Reddy’s Laboratories Telangana, India, facility received yet another FDA Form 483 after an Oct. 19-27 inspection resulted in a 25-page report detailing powdery residue in multiple places on floors and equipment, pointing to a lack of cleaning and lack of equipment maintenance, among other lapses. Read More
Over the past week, the FDA issued final guidance on assessing credibility of computational modeling and simulation in medical device submissions and notifying FDA of a permanent discontinuance or interruption in manufacturing of a device under section 506J of the FD&C Act. Draft guidance was issued on select updates for the 506J guidance and product specific guidances for drugs. Advisory committee meetings were announced for multi-cancer detection devices, pulse oximeters and the 506J devices list. Read More
Two oncology drugs that hold the records for the longest-marketed accelerated approval cancer drugs without confirmed clinical benefit and safety profiles need shorter, more focused study in a subgroup, members of the Oncologic Drugs Advisory Committee agreed in a meeting on Thursday, expressing concerns about the sponsor’s proposal for a large phase 3 trial. Read More
An Arizona company marketing an unapproved vaginal contraceptive cream has settled a federal complaint and agreed to stop distributing the product until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act). Read More
The FDA has published 40 new and revised product-specific guidances (PSG) which provide recommendations for developing generic drugs and generating evidence to support ANDA approvals. Read More
A groundbreaking treatment for sickle-cell disease and transfusion-dependent β-thalassemia using the biomedical advancement of CRISPR technology has been authorized by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for patients aged 12 and over. Read More
FDA Commissioner Robert Califf said he believes the FDA can take steps to improve the current system for postmarket evaluation of drugs and make major renovations that address its current complexities and redundancies. Read More
Upcoming events in the coming weeks and months include three FDA advisory committee meetings; MAGI 2024: The Clinical Research Conference; and webinars on medical device cybersecurity, overcoming common clinical trial challenges and FDA inspections. Read More
The manufacturer of eye drops linked to more than 80 adverse reactions, including 14 cases of blindness and four deaths, received a 15-page FDA warning letter calling the company out for lack of product sterility as well as inadequate product formulation, data integrity lapses and more. Read More