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Phased Implementation, Reporting Burden Among Industry Focal Points in Initial Feedback on FDA’s Quality Metrics Draft Guidance

Phased implementation, reporting burden, and the nuances of site versus product reporting were among the focal points of the comments by the various associations appearing at the public meeting held by FDA on August 24 to capture industry’s initial feedback on the agency’s quality metrics draft guidance.

India Unifying Pharmaceutical Departments

According to the Economic Times of India, the Indian government is planning on bringing all of the government groups that deal with pharmaceuticals under one department. Currently there are numerous separate departments that deal with individual aspects of drugs, such as patenting and licensing. The new department would work to create a more cohesive view […]

FDA 2014-2018 Strategic Priorities

FDA released a draft of Strategic Priorities for Fiscal Year 2014-2018 for public comment at the beginning of July. Five cross-cutting strategies and four mission goals are identified. The five strategic priorities are: ● regulatory science ● globalization ● safety and quality ● smart regulation, and ● stewardship. The core mission goals are to: ● […]

Hamburg Addresses Drug Quality Regulation During India Visit

In mid-February, FDA Commissioner Margaret Hamburg traveled to India to meet with government officials on quality and other regulatory topics. This visit included the signing of a “Statement of Intention” to clarify the points on which both countries will cooperate, such as: ● sharing of CGMP compliance and facility information, ● India observing FDA inspections, […]

FDASIA Section 707 Draft Guidance on Obstructing Inspections Draws Industry Comments; Investigator Subjectivity Among Issues Raised

FDA’s new draft guidance on “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection” has drawn some industry concern regarding the degree of subjectivity it affords investigators in determining when the lines have been crossed....

FDA Seeking Industry Input on Quality Metrics to Help Rationalize Its Review and Inspection System

FDA is proposing that the application of the right quality metrics could help create a more flexible and rationalized review and inspection system and is asking for industry input on what metrics would provide the most effective leverage....

SFDA Completed Ten GMP Inspections of Overseas Manufacturers in 2011

In 2011, China’s State Food and Drug Administration (SFDA) completed ten GMP inspections of firms in the US, the EU, South Korea and India that manufacture vaccines, APIs, biologics, and oral solid dosage forms and sell their products in China. The overseas inspections were announced last October (IPQ “The News in Depth” Nov. 10, 2011), […]

China’s SFDA Begins Inspections of Overseas Manufacturers

China’s State Food and Drug Administration (SFDA) is initiating inspections of pharmaceutical manufacturing facilities overseas that sell products in China as part of its ongoing effort to modernize and harmonize regulatory practices with international standards and ensure the quality and safety of medicines sold in its country.

FDA Renews Request to Congress for Additional Supply Chain Authorities

At a US Senate hearing on September 14, FDA renewed its request for new tools to more effectively and efficiently oversee the global supply chain and better protect the public from substandard, adulterated and counterfeit drug products....

Japan’s Foreign Inspections Reveal Communication Chain Gaps

Foreign inspections by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) are revealing gaps in the communication chain between marketing authorization holders in Japan, their overseas suppliers and the Japanese caretakers of the supplier’s master files, PMDA’s Liaison Officer with EMA Yoshikazu Hayashi reported at the annual meeting of the Active Pharmaceutical Ingredient Council (APIC) in Barcelona, Spain in late October....
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