Jill Wechsler

Drug manufacturers face added pressure and incentives for meeting new FDA compliance policies and priorities.

More reliable operations would accelerate product development and prevent drug shortages.

Drug makers back alternative to FDA labeling update rule.

Commissioner Margaret Hamburg discusses globalization challenges and the need for investment in regulatory science during her last weeks at the agency.

New rules for tracing drugs through the supply chain and policies for drug compounders change the regulatory landscape.

Scientists and industry experts seek effective preventive therapies to combat global disease.

Drug shortages are declining, but they’re still a serious concern for regulatory authorities, policy makers, and bio/pharmaceutical manufacturers.

The ongoing battle over drug reimbursement and pricing has raised questions about whether the pharmaceutical industry can continue to rely on high United States revenues to fund biopharmaceutical R&D.

The Center for Drug Evaluation and Research seeks a more flexible system for assessing biotech product quality.

The industry reacts to the departure of Commissioner Margaret Hamburg.

President Obama unveils his “Precision Medicine Initiative”.

Manufacturers face new rules for tracing drugs through the supply chain and compounders face stricter standards.

Industry voices concerns over draft legislation that seeks to get much needed treatments to patients.

Government and industry efforts to address manufacturing challenges move Ebola vaccine candidates into larger clinical trials.

FDA aims is to collect data regularly from manufacturers that will indicate the ability of a firm and its facilities to produce high-quality therapies on a continual, error-free basis.

An FDA expert committee has recommend approval of Zarizio, the first US biosimilar application from Sandoz, setting a milestone for generic biologic drugs and setting the stage for future approvals.

FDA’s Center for Drug Evaluation and Research implements its reorganization to bolster programs and policies to ensure drug with its “super” Office of Pharmaceutical Quality (OPQ).

Manufacturers are under pressure to develop pipelines, promote quality, and justify pricing.

FDA set several milestones in approving more new, important drugs and biologics in 2014. Breakthrough drug designations went through through the roof, speeding more new therapies for cancer and critical conditions to patients.

FDA has scheduled a public meeting in early January to assess and weigh data on the first United States application for a biosimilar therapy.

Patient access to critical experimental medicines continues to grab public attention as states enact “Right-to-Try” laws and Congress eyes establishing a national policy to provide not-yet-approved therapies to terminally ill patients.

The development and approval of new vaccines and antivirals to contain and treat the Ebola virus outbreak has become a top priority for the federal government and Congress, as seen in new policies to spur R&D and added funding for these efforts.

Spending rises on prescription drugs despite overall slow-down in health care outlays.

Operational changes at FDA and CDER aim to improve global market monitoring.

Sponsor response to FDA's breakthrough program has exceeded FDA expectations, but puts pressure on manufacturers to address formulation, stability and quality production issues very early in development.

Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes.

The United States government is ramping up support for formulation, production, and packaging of Ebola treatments.

The 2014 mid-term elections handed over control of the Senate to Republicans and boosted the GOP majority in the House, a clear blow to Obama administration policies, including the president’s landmark health reform initiative.

Most new injectable drugs and biologics are being designed as combination therapies, presenting difficult regulatory and production issues for manufacturers.

Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes.