Regulatory Watch

As drug shortages make headlines, FDA tests the Sentinel safety system and its efect on healthcare.

Food-safety, transparency, and counterfeit-drug growth will tax agency resources.

Top priorities for manufacturers include user fees, new health initiatives, and regulatory compliance.

A new center may provide evidence for improving care, but could discourage coverage of treatments.

President Obama and HHS eye innovation and countermeasures to protect public health.

Weighing the pros and cons of REMS for bringing risky products to market.

Fallout escalates from McNeil recall and Genzyme shortages as regulators review oversight.

More information may be released to improve public understanding of regulatory policies.

Manufacturers will pay new fees but anticipate expanded drug use and safeguards for innovation.

FDA lacks resources to manage expanding postmarketing responsibilities.

FDA modernizes information systems, expands access to drug safety and use information.

Vaccine R&D is surging, but continues to raise manufacturing and regulatory challenges.

Generic-drug manufacturers look to expand into biologics and complex dosage forms. This article contains bonus online-exclusive material.

The heightened focus on risk raises concerns about delays in approving new drugs.

Strict enforcement, new rules, and organizational changes signal an activist tone.

Health crises generate support for new vaccines and treatments for diseases found in developing nations.

Pressure to reduce healthcare spending has put drug rebates, price cuts, and tax hikes on the table.

REMS to improve the safe use of opioids may lead to controls on other high-risk medicines.

Agency officials and manufacturers anticipate stricter enforcement of drug safety and quality.

Government funding is slated to boost comparative studies of prescription drugs.

FDA is poised to gain authority and resources to ensure the quality of food and drugs.

Broader disclosure of drug prices and conflicts of interest are central healthcare reform issues.

The stimulus bill expands the healthcare safety net while boosting investment in health IT and comparative research.

Efforts to cut healthcare outlays will focus on drug costs, despite a drop in prescription sales.

Will more resources and new leadership fix FDA, or is a major overhaul in order?

To expand coverage amidst the economic crisis, Obama will look for ways to cut healthcare costs.

Policymakers weigh new rules to ensure the safety and quality of drugs made with tiny particles.

Manufacturers seek real-world benefits from investment in QbD and risk-management strategies. This article contains bonus online-exclusive material.

FDA is taking several measures to ensure that imported drugs meet manufacturing standards.

FDA is modernizing adverse-event reporting as part of a revolution in drug-safety assessment.