The longtime director of the Center for Devices and Radiological Health's (CDRH) Office of Compliance, Steve Silverman, plans to leave the US Food and Drug Administration (FDA) next week to pursue other opportunities, press officials have confirmed to Regulatory Focus . Silverman has been a central figure in CDRH's " Case for Quality ," an effort to improve compliance among medical device manufacturers by focusing on common quality errors across the device industry. "We...

The US Food and Drug Administration (FDA) has announced the hire of a new senior official, Cynthia Schnedar, who will serve as the director of the Center for Drug Evaluation and Research's (CDER) Office of Compliance (OC), its drug compliance enforcement division. The position had been vacated earlier this year by Howard Sklamberg , who had served as director of CDER's OC since November 2012 . In January 2014, Sklamberg was promoted to the position of deputy commis...

Medical device companies are required by law 1 to have corrective and preventive action (CAPA) procedures to identify, prevent and correct product quality nonconformities. The effectiveness of a CAPA procedure can make the difference between successfully resolving deficiencies and enduring recurring deficiencies that result in waste, inefficiency, customer dissatisfaction and, potentially, patient-related adverse events. An effective CAPA procedure protects the customer...

Drug Master Files (DMFs) are required in most countries as supporting documents for the registration of drug products. DMFs generally contain information pertaining to the chemistry, manufacturing and controls (CMC) sections of the drug submission and reflect the drug's identity, strength, purity and quality. The DMF procedure exists all over the world, from highly regulated markets (HRMs) through nearly regulated markets (NRMs). The HRMs, such as the US, EU, Japan, Can...

The US Food and Drug Administration (FDA) sent more warning letters during 2011 than at any time during the previous 13 years, and FDA official told a San Francisco chapter meeting of the Regulatory Affairs Professionals Society (RAPS). Speaking at a 27 July meeting, Barbara Cassens, director of FDA's San Francisco District office, highlighted recent FDA enforcement trends, including warning letters, injunctions, arrests, convictions, and the most common deficiencies exh...

When an audit is conducted, company management expectations are simple: They want to know whether there is a problem, how big it is and whether or not it is being fixed. All too often, audits, and their reflection in follow-up communications, fail to live up to that role because most audit processes and reports fail to take full advantage of, and communicate, the information they gather. Anyone who has been audited has probably heard the phrase: "I'm going to have to wr...

The US Food and Drug Administration (FDA) sent two untitled warning letters to pharmaceutical companies in as many days in June, warning two companies regarding alleged infractions contained within marketing videos. The first of the letters cited Valeant Pharmaceuticals -which owns the New Drug Application for Xenazine, actively marketed by Lundbeck-for purportedly omitting risk information from a video posted on its website. While the majority of the product's risk inf...

Jakafi® (ruxolitinib) was approved 1 by the US Food and Drug Administration (FDA) on 16 November 2011 for the treatment of intermediate or high-risk myelofibrosis (MF) including primary MF, post-polycythemia vera MF (PPV-MF) and post-essential thrombocythemia MF (PET-MF). Prior to this time, there were no approved products, and therefore no precedent for regulatory endpoints in this orphan disease. MF is a highly symptomatic 2 myeloproliferative neoplasm (MPN), cha...

The US Food and Drug Administration (FDA) has withdrawn its compliance policy guide (CPG) governing the registration of blood banks and other companies  that prepare human blood and blood products-the third such withdrawal made this week. In a Federal Register notice posted late on 26 June, FDA said it believes its 1974 CPG, Registration of Blood Banks, Other Firms Collecting, Manufacturing, Preparing or Processing Human Blood or Blood Products (CPG 7134.01) , ...

Chinese regulatory authorities have announced the expansion of a probe into pharmaceutical capsules illicitly laced with Chromium, saying they have arrested nine more people, detained a further 45 and seized more than 77 million capsules, reports Reuters . Chromium is a heavy metal that has been associated with cancer in some circumstances. Chinese authorities originally announced on 15 April that they had found 13 pharmaceutical products-including antibiotics-to have b...

A national campaign targeting counterfeit drugs was launched on 27 March jointly by the State Food and Drug Administration (SFDA) and Ministry of Public Security through a notice issued to all provinces, autonomous regions, and municipalities.  The notice calls for mutual coordination and cooperation between local food, drug and law enforcement agencies in "combating" the production and sales of counterfeit and inferior drugs.  Local authorities are encouraged...