Outgoing FDA commissioner said his direct contact with center directors helped agency advance policies and helped centers solve their problems.

Recent Q&A draft guidance is aimed at assisting sponsors in planning and conducting risk-based approaches to monitoring, but ACRO’s Doug Peddicord says agency needs to take a more straightforward, proactive approach to encouraging the move away from 100% source data verification.

First suit challenging biosimilar litigation settlements ratchets up pressure on AbbVie's "patent thicket" and licensing strategy.

Congressional hearings on the recent outbreaks of measles and other vaccine-preventable diseases offered a positive theme for the industry during the ongoing drug pricing debate.

Clonal neoantigen immunotherapy developer Achilles Therapeutics tells the Pink Sheet how the regulatory landscape for advanced therapies might not be as tricky as it used to be.

Draft guidances reflect the agency’s thinking on when patients with HIV/hepatitis infection, brain metastasis, organ dysfunction or prior malignancies, as well as pediatric patients, should be enrolled in cancer trials; FDA also finalizes recommendations on adolescent enrollment in adult studies of oncology drugs.

Faced with a proposed regulation that aims to eliminate rebates and an upcoming hearing on Capitol Hill, US pharmacy benefit managers including OptumRx are working to validate the concept of rebates when redirected to patients at the point-of-sale. 

Amgen seeks a preliminary injunction to halt US sales by Cipla and says it will take steps to stop Piramal’s sales; in its antitrust lawsuit, Cipla alleges Amgen paid to license Teva products under the companies’ patent settlement, which resulted in Teva pulling its generic off the market shortly after launch.

Assessing how closely GSK's OTC brands including Panadol compete with Pfizer's Robitussin and other OTC brands is the aim of investigation by Australia's Competition and Consumer Commission into the pharma giants' proposed consumer health joint venture. ACCC states particular interest in importance of Panadol, Voltaren and Advil brands, and whether GSK and Pfizer compete closely in supply of pain relief, gastrointestinal and cold and flu relief products.

Company argues there is a clinical need for its ready-to-use, preservative-free compounded formulation of vasopressin but agency says Vasostrict is available in a dose without the preservative.

Legislative proposals described in the US FDA’s FY 2020 budget request justification document would give the agency more authority to oversee business continuity planning at pharmaceutical companies with the idea of preventing shortages of essential drugs.

Firms that manufacture sterile drugs on traditional filling lines instead of using restricted access barriers or isolators risk tighter scrutiny from FDA inspectors, agency official says. Yet it remains unclear how much of a difference the increased oversight will make.