The United States Pharmacopeia (USP) and the FDA are working together to promote opportunities for sponsors to develop new generic medications for off-patent drugs that currently lack an approved generic equivalent. Read More

In this edition of Quick Notes, Akili snags approval for a video game-based ADHD treatment, Johnson & Johnson’s orthopedics unit wins FDA authorization for a partial knee replacement robotic-assist system, Getinge secures 510(k) clearance for clinical decision support software used to improve patient outcomes, and Philips implants the first patient with its Duo Venous stent system for a type of cardiovascular disease. Read More

Parameters for slowing or blocking an FDA drug or device inspection are now available to manufacturers and storage facilities, following the agency’s release of its final guidance on the subject Friday. Read More

The war against fake GLP-1 inhibitors is heating up, with Eli Lilly filing six suits against med spas and wellness centers selling unapproved versions of its patented tirzepatides — Mounjaro and Zepbound — with WHO and National Association of Boards of Pharmacy (NABP) also issuing alerts on the problem. Read More

This edition of Quick Notes focuses on FDA approvals for expansion of the age allowed for a treatment for muscular dystrophy, an expanded age indication of an RSV vaccine, a next-generation tyrosine kinase inhibitor (TKI) for certain solid tumors, a drug for certain thyroid cancers and an autoinjector for adults with moderate-to-severe atopic dermatitis. Read More

The FDA’s draft guidance on real world evidence (RWE) for non-interventional studies is too high level and lacks enough detail to guide the drug and biologics industry which limit its usefulness, say stakeholders who commented on the draft. Read More

The FTC submitted comment supporting the US Patent and Trademark Office (USPTO) April proposed rule that seeks a variety of changes to the Patent Trial and Appeal Board (PTAB) proceedings including when patent settlement agreements must be disclosed. Read More

The FDA’s draft guidance on interchangeability describes considerations for switching studies to support a product as interchangeable with a reference product, given the limited risk the FDA has seen in switching between biosimilars and the reference product. Read More

Government spending on the 340B Drug Pricing Program rose almost 20 percent per year from 2010 to 2021, spiking from $6.6 billion to $43.9 billion, with 88 percent of the growth attributed to hospitals and their affiliated off-site clinics, not federal grantees, says a report from the Congressional Budget Office (CBO). Read More