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The UK government, England’s National Health Service (NHS) and the Association of the British Pharmaceutical Industry (ABPI) have agreed to a drug pricing deal that will save the government £14 billion ($17 billion) over five years, and support research investment. Read More
As the first session of the 118th Congress continues, FDAnews will track important pending legislation, that has been acted on since July 1, to keep you updated on laws and regulations that could impact your business. Read More
Companies that make pharmaceutical, biologic and medical devices are caught hiding relevant information or purposefully delaying applying for patents at the U.S. Patent & Trademark Office (USPTO) in gamesmanship moves that occur in the medical field far more than in other industries, according to recent reports. Read More
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 Draft guidance was issued on select updates for the 506J guidance and product specific guidances for drugs.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