Regulatory Oversight and Compliance

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

FDA's draft guidance on aseptic processing contains some inherent difficulties, including unrealistic expectations of sterility and microbial quantification, an absence of harmonization with international rules, and failure to support new technologies or a risk-based approach. The authors propose a science-based alternative.

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.

The authors describe the solicitation of industry input for the guidance through a process that included a 2002 meeting of the Advisory Committe on Pharmaceutical Science and the subsequent formation of the PQRI Aseptic Processing Working Group.

Regular update from Washington.

On 20 February 2003, the US Food and Drug Administration (FDA) published a new draft guidance relating to 21 CFR Part 11. The new guidance mainly affects the compliance requirements of systems with a low risk and low impact on product quality; however, systems with a high risk and high impact on product quality, such as chromatography data systems or laboratory information management systems (LIMS), remain unaffected, as this article describes.

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.

As the US Food and Drug Administration (FDA) strives to streamline its regulatory process for bringing new drugs to market (see sidebar "Manufacturing data key to spurring drug development"), efforts to ensure the quality, safety and efficacy of dietary supplements and herbal medicines are gaining more attention.

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.

FDA is set to revise CGMPs to encourage new manufacturing technologies and develop improved agency policies to ensure drug quality and safety.

Congress debates legislation for a Medicare drug benefit while the industry expresses concerns about import control, drug counterfeiting, and patent rights.

In response to increasing concern about drug safety, FDA has implemented several administrative and policy changes, inclduing the new Office of Pharmacoepidemiology and Statistical Science and a renewed focus on risk assessment.

To fund expanded FDA operations designed to streamline drug development and approval, FDA and industry representatives have negotiated the Prescription Drug User Fee Act III.

FDA cites manufacturing difficulties as a main contributing factor to recent drug shortages, which mainly involve injectibles and vaccines.

ICH continues its efforts to establish universal drug development standards and testing as pharmaceutical manufacturers press for additional FDA guidance on specifications.