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.

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.

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.

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.

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

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

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

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

Demand for new therapies and vaccines spotlights production challenges.

FDA demands accurate manufacturing and test information to ensure product quality.

Attendees at the Bio-Process Systems Alliance annual summit discuss the benefits of single-use technology in biopharmaceutical manufacturing.

FDA seeks high quality applications and products to facilitate approvals and reduce safety and supply problems.

Stakeholders face challenges and benefits from a more secure pharmaceutical supply chain.

Supplier Audit Program Marks Progress

Regulators and industry organizations explain policies and standards to manufacturers and authorities in all regions.

New formulations and expanded vaccine production are encouraged.

New identifiers and tracking requirements aim to block illegitimate products.