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Sponsor/CMO Communication Gaps Will Have Negative Inspection Fallout, FDA Field Investigator Cautions

The lack of communication between sponsors and contract manufacturing organizations (CMOs) – particularly those located abroad – can make the FDA inspection process a difficult one and can jeopardize the compliance position of the CMO involved as well as the approval of the sponsor’s application, agency investigators are warning....

The Monthly Update for November is Now Available – A Special Report on the Crisis in Pharmacy Compounding and its Implications

In this Monthly Update, IPQ departs from its usual format encompassing the CMC and GMP developments in the U.S., Europe, and internationally to provide a special report on the causes of the health crisis that has unfolded from fungal contamination in pharmacy compounded injectables and the far-reaching implications that extend across the U.S. drug regulatory arena....

FDASIA’s Catch-All Title XI Includes Provisions on Medical Gases and Nanomaterials

A new system for the registration of medical gases and FDA participation in standard setting for nanotechnology particle-containing products are among the provisions in the catch-all Title XI of the Food and Drug Administration Safety and Innovation Act (FDASIA) that will further the Act’s impact on CMC and GMP regulatory processes....

Initiatives to Strengthen FDA’s Generic Drug Review Process Include OGD Supplement and Peptide Teams

FDA’s Office of Generic Drugs (OGD) has created dedicated teams for the review of supplements and peptide drugs as part of an office-wide effort to improve the efficiency and effectiveness of its review processes and explore where policy and resource improvements are needed....

EMA’s Biosimilar Quality Guideline Redraft Sharpens Focus on Target Profiles and Lifecycle Changes of Reference Product

The new draft of EMA’s biosimilars quality guideline includes a heightened focus on understanding the quality target product profile (QTPP) of the reference product and the changes that have occurred to the quality attributes over the reference product’s lifecycle....

FDA Releases Final Guidance on PET Drug Media Fills; Application Filing Deadline Extended

FDA has finalized a guidance on positron emission tomography (PET) drug media fills that was released as a draft last September and has effectively extended the December 2011 deadline for PET drug application submissions until June....

Several Drug Substance Guideline Initiatives Moving Forward in Europe and ICH

Europe and ICH have several guideline initiatives underway that will help clarify and harmonize the regulatory expectations for drug substances and the control of their impurities....

US/Canada Regulatory Cooperation Council Addresses DMF, GDP and OTC Harmonization

At the end of January, over 240 industry representatives and US and Canadian government food and drug officials met in Washington, DC to review progress and provide direction to working groups dealing with the 29 initiatives included in the US/Canada Regulatory Cooperation Council’s Joint Action Plan.  Initiatives on harmonizing regulatory standards for drug master files […]

TGA Releases Revised OTC Guidelines for Public Comment

Australia’s Therapeutic Goods Administration (TGA) has released guidelines for comment that revise its framework for the application and approval processes for over-the-counter (OTC) drugs.  Comments are due by February 11. The “Australian Regulatory Guidelines for Over-the-Counter Medicines” (ARGOM) is a set of documents that seeks to: ● provide information to help sponsors of OTC medicines […]

FDA Publishes Interim Final Rule on Sole Source Reporting Requirements

In December, FDA published an interim final rule amending post-marketing reporting requirements for sole manufacturers of lifesaving drugs as part of its effort to address a recent surge in drug shortages.  The interim rule becomes effective on January 18. While existing regulations require that only permanent discontinuances be reported to FDA, in practice some manufacturers […]
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