Regulatory Oversight and Compliance

A new FDA policy emphasizes quality control over GMP compliance in producing clinical trial supplies.

FDA is proposing revisions to the drug user fee program while it weighs changes for drug safety initiatives and expanded vaccine production.

FDA Issues Dispute–Resolution Guidance

Manufacturers, FDA, and research organizations are collaborating on efforts to spur innovation and streamline drug production.

CDER is reorganizing staffs and developing new policies to encourage industry adoption of quality production systems.

New FDA Guidance on Electronic Common Technical Document Submissions

New leadership must address political and scientific issues as the Medicare drug benefit alters manufacturer incentives.

von Eschenbach Drops NCI Hat…for Now

Ensuring access to quality medicines while ramping up production requires attention to supply chains, bioequivalence testing, and patent and regulatory issues.

FDA Places All Andrx ANDAs on Hold

Commissioner Crawford’s top priority is to restore public confidence in FDA oversight of drug safety and quality.

New Guidance May Speed Generic Approvals

Although new drug development usually focuses on clinical and preclinical research, moving innovative products from clinical testing to market mainly involves overcoming manufacturing capabilities and production challenges. Ensuring access to consistently high-quality critical vaccines and therapies needed to counter bioterrorism attacks is a topic frequently debated. Product shortages are leading to policies that expand US drug and vaccine manufacturing and ensure that US regulatory and healthcare policies avoid erecting roadblocks to high-quality drug production.

Proposals to expand drug adverse event monitoring will publicize emerging safety concerns and strengthen post-marketing compliance efforts.

Officials at the US Food and Drug Administration are working with industry and academia to develop more efficient and reliable drug production processes that can ensure a consistent supply of high-quality therapies. A modern manufacturing system based on harmonized regulatory policies across global regions is critical for meeting public demand for safe and effective medicines, while also reducing production costs and eliminating waste.

New Excipient Guidance Doesn?t Fill Regulatory Gap

FDA is finalizing guidances and enforcing compliance with manufacturing standards as part of its efforts to ensure drug safety.

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

FDA Finalizes Guidances on Minimizing Drug Risk and Submitting Pharmacogenomic Data

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

CBER Draft Guidance for Spore-Formers and Plasmid Vaccines

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.