Jill Wechsler

FDA’s commissioner addresses opioid abuse, drug costs, and manufacturing quality.

Accelerated development of new preventives raises challenges for efficient CMC evaluation and production.

Congress passed a $1.3-trillion omnibus budget bill March 22, 2018 that increases federal support for biomedical research and health programs for fiscal year 2018.

The FDA commissioner outlined the agency's initiatives to reward innovation and biosimilars development.

Manufacturers face demands for timely information on clinical studies, product recalls, and approvals.

The Trump budget boosts funding for FDA but squeezes resources for NIH and healthcare.

Gottlieb promoted the development of biosimilars and safer opioid packaging at a briefing sponsored by Alliance for a Stronger FDA and the Pew Charitable Trusts.

New programs and initiatives by industry examine rising healthcare costs.

Manufacturers tackle regulatory and competitive issues to develop complex therapies and biosimilars.

The President described US drug costs as unfair and stated that prices will come down.

FDA and industry weigh broader use of prior knowledge in biotechnology testing and production.

Will Alex Azar’s experience in the pharmaceutical industry help or hurt the initiative to keep medications affordable?

Policy makers look to boost generic drugs, curb opioid abuse, and maintain incentives for innovation.

New tax legislation may result in savings for biopharma companies.

An increasing number of warning letters shows that FDA is observing more problems with pharmaceutical contract manufacturing.

New gene therapies and combination products require innovative regulatory approaches.

Experts slam drug prices and endorse government price negotiations and curbs on drug advertising.

Manufacturers and trading partners struggle to meet drug tracking requirements

FDA seeks to focus on problematic facilities and inform firms quickly about site problems.

FDA and manufacturers strive to prevent drug shortages from Hurricane Maria.

Industry and FDA face new fee structures and new challenges in implementing fee initiatives.

Biopharmaceutical companies developing new competitive biotech therapies have pressed hard for clarity on the testing and data required by FDA to gain market approval of biosimilars that can be filled by a pharmacist without prescriber preapproval.

Continued industry investment in advanced biologics will raise further regulatory challenges and require innovative manufacturing systems.

FDA works with industry on strategies for assuring high-quality regenerative medicines.

High-priority issues requiring immediate attention leave little time for Congress to consider drug access proposals that have limited bipartisan support.

Efforts to establish an international system for identifying and tracing drugs through the global supply chain are moving forward.

The Senate voted 94–1 to approve legislation reauthorizing user fees and a series of program changes.

FDA urges manufacturers to seek fast approval of “high-need” generics and targeted therapies. 

Manufacturers are seeking greater oversight of how providers reimburse for and dispense covered drugs.

CDER’s Janet Woodcock endorses modern drug manufacturing to ensure access to safe and reliable medicines.