Results from a single-arm study cannot support representations on overall survival, progression-free survival and disease control rate for the cancer drug, the Office of Prescription Drug Promotion said in another “untitled” letter implicating the agency’s CFL guidance.
Cell and gene therapy manufacturers must consider the practicalities of their product within the context of a health care system before it comes onto the market to be successful, experts from Novartis, AstraZeneca and England’s National Health Service say.
A global collaborative inspections pilot reduced the number of individual inspections for participating manufacturing facilities, demonstrating that multiple regulatory authorities can carry out joint inspections using a mix of on-site and remote approaches.
The UK’s medicines regulator is pressing on with clarifying its expectations on decentralized manufacturing of medicines.
Sponsors should review longstanding agency concepts on consumer-friendly language and claims limitations, along with Office of Prescription Drug Promotion research and enforcement, when applying the 2018 CFL guidance to direct-to-consumer advertising, Sidley Austin’s Cope says.
Health and Human Services Secretary Robert F. Kennedy Jr. is moving FDA Chief Counsel Robert Foster to a new senior position as Chief Counsel for Food, Research, and Drugs at HHS. Hilary Perkins will become FDA chief counsel.
Newly proposed legislation for bolstering the EU’s drug manufacturing capacity and reducing its overreliance on foreign manufacturers includes a number of measures, such a requirement for EU countries to prioritize the security of supply over price when procuring drugs.
The new act aims to tackle drug shortages and create a better framework for establishing manufacturing facilities of essential medicines in the EU. It should recognize differences between generics and innovative products, says industry group EUCOPE.
The estimated costs to the pharmaceutical and cosmetics industry of introducing a fourth level of urban wastewater treatment are unclear, with the European Commission’s estimate of €1.2bn in dispute.
A retrospective analysis does not support a claim that multiple myeloma patients are more adherent to Hemady than generic dexamethasone, OPDP said in an "untitled" letter suggesting increased enforcement focus on promotions leveraging the agency’s 2018 CFL guidance.
Companies that fail to provide patient health data for secondary use when requested under the new European Health Data Space could be fined and also prevented from making access requests from other entities, a European Commission representative says.
Lilly is broadening the range of single-use vial dosage forms of its obesity drug and lowering prices of existing doses for self-paying customers, but maintains it can handle increased demand as compounding ends.
The explosion in pharmacy compounding as a source of GLP-1 weight loss medications has put the FDA in a tough spot to defend its drug shortage policies, but it is not the first time that compounding has posed a potentially significant threat to agency authorities.
Sponsors should consider the DTC ad's audio as the major statement about a prescription drug’s side effects and then choose strategically how to display the accompanying text. TV ads are now employing banners and larger text to satisfy the rule’s “dual modality” requirement.
Reporter and editors from the Pink Sheet and Medtech Insight discuss the impact of the FDA’s decision to call back many of the employees it laid off, the decision to cancel an upcoming FDA advisory committee meeting on flu vaccines, and Eli Lilly’s plans to increase domestic manufacturing.
Eli Lilly's move is said to be part of broader industry campaign to invest in America and avoid President Trump's tariffs, but the company also said tax reform is necessary to make the investments.
The Vaccines and Related Biological Products Advisory Committee meeting next month was scheduled to select strains for the 2025-2026 flu vaccine. The cancellation could mean delays in vaccine availability.
Regulatory authorities from multiple regions are considering extending a pilot project related to collaborative assessments of post-approval chemistry, manufacturing and controls changes, with a focus on the supply of critical medicines.
The EU’s new Product Liability Directive will make it easier for European consumers to seek compensation relating to defective products even if manufacturers are based outside the bloc. Legal experts caution that this could have substantial implications for pharmaceutical companies.
A declaratory order removing semaglutide from the FDA shortages list duplicates much of the language in a December decision still in litigation that declared Eli Lilly’s tirzepatide products Mounjaro and Zepbound were no longer in shortage.