It has been two years since FDA published its draft guidance on Data Integrity and Compliance with cGMP, with much fanfare and some legitimate criticism from stakeholders, particularly criticism regarding some overarching assertions that the agency made that are difficult to justify on the basis …
On October 31st, FDA made its long anticipated announcement recognizing the first European drug regulatory authorities capable of conducting inspections of manufacturing facilities that meet FDA requirements. The eight countries that were announced are: Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom. The …
According to a European Medicines Agency (EMA) press release issued on August 23, 2017, the FDA, the European Commission (EC), and the European Medicines Agency (EMA) recently signed a new confidentiality commitment that allows the FDA to share non-public and commercially confidential information, including trade …
This was FDA’s recent admonition to ChemRite CoPac, Inc. (ChemRite), in a Warning Letter issued on June 29, 2017. Apparently the manufacturer of several over-the-counter oral rinses and oral moisturizing drug products uses the same equipment to manufacture numerous non-pharmaceutical materials, including an industrial car …
In late June, Pacira Pharmaceuticals informed the FDA, the European Medicines Agency, and Health Canada that the company had filed a notice with the U.S. Securities and Exchange Commission, advising of its intent to discontinue all future production of DepoCyt® due to “…persistent technical issues …
On June 23, 2017 FDA published a notice in the Federal Register entitled: “Submission of Proposed Recommendations for Industry on Developing Continuous Manufacturing of Solid Dosage Drug Products in Pharmaceutical Manufacturing; Establishment of a Public Docket”. This notice relates to a workshop FDA hosted on …
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 …
