Earlier this year, we blogged about FDA’s Field Alert Report (or FARs) reporting requirements under 505(k) of the Federal Food, Drug, and Cosmetic Act. The requirements have been in effect since 1985, when the agency promulgated the regulatory provision at 21 CFR 314.81(b)(i). At the time …
Last week, the United States and the European Union agreed to recognize each other’s drug cGMP inspections. The agreement reached (see here and here) amends the Pharmaceutical Annex to the 1998 U.S. – E.U. Mutual Recognition Agreement, with a view to avoiding duplicative inspections and …
FDA’s Field Alert Report (or FARs) reporting requirements are authorized under 505(k) of the Federal Food, Drug, and Cosmetic Act. The requirements have been in effect since the agency promulgated the regulatory provision at 21 CFR 314.81(b)(i) in 1985. The regulatory provision states, in part, …
By Jay W. Cormier – After three years of considering public comments on the draft, in last Wednesday's Federal Register, FDA issued its final FDA Guidance for Industry regarding Contract Manufacturing Arrangements for Drugs: Quality Agreements. With this Final Guidance, FDA has clarified its scope, specifically with …
By Mark I. Schwartz* – On March 2, 2015, investigators from the U.S. Food and Drug Administration walked into a factory at Zhejiang Hisun Pharmaceutical in China to conduct an inspection. According to the investigators, at one point a lab employee pulled a memory stick from …
By Karla L. Palmer – FDA announced last week the availability of a draft guidance document titled, “Insanitary Conditions at Compounding Facilities.” This draft is FDA’s first attempt to assist compounding facilities and state regulators in identifying “insanitary conditions so they can implement appropriate corrective actions.” …
By Mark I. Schwartz – The Mutual Reliance Initiative was announced by FDA a couple of years back. It has as its goal “…to increase…[FDA’s]…exchange, with the European Commission and the European Medicines Agency, of information that is critical to making decisions that protect our public …
In recent years, the level of scrutiny on foreign pharmaceutical manufacturing facilities in countries like China and India has skyrocketed—along with the demand and dependence of western countries on the supply of goods coming from those facilities. With the international pharmaceutical supply chain imperiled …
By James C. Shehan – In a bluntly-worded warning letter to contract manufacturer Sri Krishna Pharmaceuticals Ltd. issued April 1, 2016, we see another example of increasing FDA concern over data integrity issues at non-US drug manufacturing facilities, particularly those in India. This rather remarkable letter contains …
Hyman, Phelps & McNamara, P.C. (“HP&M”) is proud to announce the publication of its FDA Deskbook, incorporating more than a century of experience of HP&M’s attorneys from positions in the government and regulated industry. The FDA Deskbook provides a comprehensive resource that details the ins-and-outs …
By Mark I. Schwartz & Douglas B. Farquhar - After several years of observing an increase in data integrity issues, particularly with overseas drug manufacturers regulated by CDER, on Thursday, April 14th, FDA issued a question-and-answer-based draft guidance entitled “Data Integrity and Compliance with cGMP”. We …
By Andrew J. Hull – FDA often seeks permanent injunctions against FDA-regulated companies that allegedly run seriously afoul of FDA’s cGMP requirements. FDA usually asks courts, in granting a permanent injunction (the agency’s most powerful civil enforcement tool against U.S. facilities), to order the complete shutdown …
By Mark I. Schwartz – One of the pre-eminent rules in QSR and cGMP compliance is to document one’s activities. In the eyes of FDA, the “failure to document” is often equated with the failure to perform the underlying regulated activity. FDA takes this position principally …
By Mark I. Schwartz – There have been at least four FDA initiatives, in the works for some time that, in the coming years, will change the way pharmaceutical (and indeed all FDA) inspections are conducted. We think you should know about these initiatives, and how …
By Mark I. Schwartz – Unlike solid oral dosage form drugs that don’t require sterilization, generally, parenteral drug products must be sterilized and, due to their nature, many parenteral drug products cannot be terminally sterilized. This leaves aseptic manufacturing. In the aseptic process, the drug product and …
