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Pharmacy Compounding Legislation Introduced in Both Houses of Congress Provides for FDA Regulatory Flexibility and Inspection Authority

Legislation has been introduced in both houses of Congress that would provide FDA with the power and flexibility it needs to define the regulatory requirements for high-risk compounding operations and the authority to inspect those that engage in interstate commerce....

FDASIA Title VII Implementation Priorities and Action Plans Taking Shape

FDA has been sorting through the multi-faceted supply chain provisions of Title VII of the FDA Safety and Innovation Act (FDASIA) to identify which should be tackled first and to put action plans in place to implement them....

IPQ Monthly Update — April, 2013

The annual conference of the Food and Drug Law Institute (FDLI), held in downtown Washington in mid-April, again provided an important venue for FDA to deliver a “state of the agency” address on the key legal, legislative and regulatory developments during the previous year and what to expect in the year to come....

Pharmacy Compounding Will Remain Center Stage as FDA’s Focus Intensifies on Drug Quality, Hamburg Tells FDLI

Pharmacy compounding will remain center stage as FDA’s focus on drug quality continues to intensify, FDA Commissioner Margaret Hamburg told attendees at the 2013 Food and Drug Law Institute (FDLI) Annual Conference in late April in Washington, D.C....

FDASIA Implementation and a Sharpened Focus on Quality Head Center for Drugs’ Agenda

The impact of the Food and Drug Administration Safety and Innovation Act (FDASIA) on the Center for Drug Evaluation and Research (CDER) is beginning to be felt as the center comes to grips with implementing the requirements of the Act and the organizational effort it will take to meet them....

IPQ Monthly Update — March 2013

The March Monthly Update is centered on the complex web of issues around drug shortages and their interconnection with the compliance problems at contract manufacturers and large scale pharmacy compounders, which in effect serve as sterile product contract manufacturers for hospitals....

The Accelerated Recovery Initiative on Drug Shortages is Gaining Momentum – Pilot Program Underway

The Accelerated Recovery Initiative (ARI) – an FDA/industry partnership being coordinated by pharma data manager IMS – is gaining momentum in its effort to forecast, prevent, and mitigate the impact of drug shortages, and a pilot program is now underway....

FDA and EU Inspectors Draw Insight at Contract Manufacturers Into GMP Enforcement/Drug Shortage Crosscurrents

U.S. and European health agency inspectors are gaining more insights during their inspections of contract manufacturers into the complexities of balancing GMP enforcement with drug shortage prevention....

FDA and ISPE Seek Stakeholder Input to Improve Drug Shortage Prevention and Mitigation Strategies

FDA and the International Society for Pharmaceutical Engineering (ISPE) are both surveying stakeholders in the pharmaceutical supply chain to help shed light on the causes of drug shortages and formulate better prevention and mitigation strategies....
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