Jill Wechsler

Innovators and generics makers are staking out positions on follow-on proteins and other manufacturing issues.

New fixed-dose combination drugs aim to enhance safety and efficacy, while regulators clear a path for more drug–device combination products.

Concerns about risky medicines may reduce pressure to expand drug imports while boosting demand for more comparative analyses of therapies.

Safety issues and shortages may slow down new drug development and FDA reforms

Blockbuster drugs turn out to be risky business, while contamination problems shut down flu vaccine production.

Phase II of FDA's GMP modernization plan may involve revising regulations to fit new policies and inspection and review programs.

FDA and industry discuss proposals for regulating combination diagnostics, medical devices, and pharmacogenomic-based drug products.

FDA is re-engineering the CMC review process for innovator and generic drugs and backing risk-based ICH quality standards.

FDA's latest proposal focuses on electronic health systems for filing drug labeling information and facility and product data.

Decisions to accelerate the approval of AIDS combination drugs, reject the over-the-counter status for the morning-after pill, and limit support for stem cell research are hot political topics.

Congress is proposing legislation to legalize drug importing and holding hearings about emerging options.

New technologies, along with changes in FDA oversight, may provide a critical path to make more new drugs available more quickly to patients.

FDA relies on e-chips to thwart bogus products, and drops paper pedigrees and unit-of-use packaging.

Healthcare coverage and costs remain prime concerns for FDA as the number of uninsured Americans continues to grow.

FDA expands electronic data submission programs to improve regulatory operations and ensure appropriate and safe drug use.

The new Medicare bill affects pricing and coverage, revises payment formula, and clarifies generic patent issues.

FDA initiatives aim to spur the development of more-affordable treatments and ensure safe product use.

FDA's new policies intend to make GMP inspections more efficient and apply to stricter rules to high-risk products and processes.

FDA offers new policies to encourage modern manufacturing approaches and automated systems, to simplify postapproval changes, and to avoid problems with sterile products.

FDA and manufacturers seek to curb drug counterfeiting while legislators consider liberalizing drug importing policies to cut pharmaceutical costs.

Manufacturers face challenges from FDA's plans to streamline the drug review and development processes aimed to spur innovation.

Biotech firms face new issues as FDA weighs policies to streamline generic-drug approvals and reduce patent disputes.

FDA's plan to establish pharmacogenomic policies spurs concerns among manufacturers, particularly in regard to how the policies will affect new-drug testing and approval.

FDA resolves the bar code labeling debate, releases its GMP requirements for dietary supplements, and proposes a comprehensive adverse-event reporting system.

FDA's newly launched risk-based approach to GMP regulation spurs signficant changes in the agency's approach to inspection processes, postapproval changes, and 21 CFR Part 11 enforcement.

Concerns about the safety and efficacy of dietary and herbal products are generating manufacturing requirements and analytical standards for ingredients.

Health experts are recognizing teh need to plan for global manufacturing of new treatments for AIDS and other diseases.

The establishment of a Medicare pharmacy benefit tops the to-do list of industry-related policy issues for 2003.

Reform legislation about generic drugs remains at the forefront of debate as innovator companies poise to challenge FDA proposals regarding patent laws.

FDA is juggling momentous changes, including new leadership and the proposed transfer of oversight for therapeutic biotech drugs.