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SUPAC Manufacturing Equipment Addendum

A final scale-up and post-approval changes (SUPAC) addendum on manufacturing equipment was issued by FDA in December. It presents filing requirements for broad categories of unit operations when making equipment changes. The addendum supersedes the former equipment addendum in SUPAC-IR/MR, for solid oral dosage forms, and SUPAC-SS, for non-sterile semisolid dosage forms. A draft of […]

FY 2014 FDA 483 Data Summary

FDA has released a summary of the data on form 483s issued in FY 2014. 645 483s were issued for drugs, 146 for biologics, and 337 for veterinary medicines. Most frequently cited for drugs was QC unit procedures (21 CFR 211.22(d)) with 145 observations, followed by lab controls (211.160(b)) with 109, and failure investigations (211.192) […]

FDA/EMA QbD Parallel Assessment Q&A

In mid-December, FDA and EMA began publishing a series of joint question-and-answer documents that outline the conclusions of their first parallel assessment of quality-by-design (QbD) elements of a marketing authorization application. The first one covers the level of detail expected in a QbD submission. FDA and EMA will publish additional question-and-answer documents on other QbD-related […]

Comments Requested on Revisions to Canadian Product Monograph

In mid-December, Health Canada requested comments on a revised draft of its product monograph requirements. The purpose of the revisions to the draft were to provide: ●restrictions on the reference section ●more clarity on comparator data expectations● more clarity on adverse reactions● more specificity with respect to pediatric data● streamlined toxicology reporting ● streamlined pharmacology […]

FDA Creates Compounding Pharmacy Advisory Committee

FDA created a compounding pharmacy advisory committee in mid-December. The committee consists of 12 voting and two non-voting members and is designed to give advice and recommendations relating to regulatory changes for compounding manufacturers and the implementation of the compounding provisions in Title 1 of the Drug Quality and Security Act (DQSA) (see IPQ December […]

Three FDA Guidances on Drug Supply Chain Security Act (DSCSA)

In late November and December, FDA issued three more guidances on implementing the provisions of DSCSA – the track and trace (Title II) component of the Drug Quality and Security Act (DQSA) (IPQ January 23, 2014). Title I of DQSA addresses compounding. The three new DSCSA guidances cover:● the situations in which FDA will delay […]

Consent Decree at Compounder Main Street Family Pharmacy

In early December, FDA completed legal actions against compounding pharmacy “Main Street Family Pharmacy” that followed from mid-2013 FDA inspection findings of insanitary conditions and numerous other deviations from cGMPs. The company and its co-owner pleaded guilty to misdemeanor criminal violations of the FD&C act and entered into a civil consent decree

Draft FDA Guidance on Obtaining a REMS Equivalence Letter

In early December, FDA released a draft guidance on how to request a letter stating that a potential applicant’s bioequivalence (BE) study protocol contains safety protections comparable to those in the risk evaluation and mitigation strategy (REMS) with elements to assure safe use (ETASU) applicable to the reference listed drug (RLD). Obtaining a REMS equivalence […]

Canada Releases Harmonized Requirements for Batch Certification

In early December, Health Canada created an internationally harmonized batch certificate that allows importers to have necessary quality information on hand in case it is needed by companies or regulators.

Final Guidance on Unique Facility Identifier Registration

In November, FDA released a procedural guidance, “Specification of the Unique Facility Identifier [UFI] System for Drug Establishment Registration.” The guidance addresses the FDA Safety and Innovation Act (FDASIA) requirements for defining the UFI system for registration of domestic and foreign drug establishments. The guidance notes that at this time, FDA’s preferred UFI for a […]
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