Gilead, Novo Nordisk, Eisai and AbbVie have been singled out as the only companies that were not found by a court or regulator over the past two years to have breached criminal or civil laws or codes of conduct related to corruption or unethical marketing, according to the 2016 edition of the Access to Medicines Index. Background Every two years since 2008, the Access to Medicine Foundation publishes a ranking system analyzing 20 different pharmaceutical companies again...

Despite all of the public discussion about FDA's enforcement approach in the off-label promotional arena, the agency continues to take action against any perceived unlawful promotion. Recently, FDA issued Notice of Violation letters to drug companies for promoting their investigational new drugs as safe and effective. Introduction The US Food and Drug Administration's Office of Prescription Drug Promotion (OPDP) did not take the summer off, despite the uncertainty sur...

France’s National Agency for Medicines and Health Products Safety (ANSM) on Monday released a new statement of serious good manufacturing practice (GMP) non-compliance for India-based active pharmaceutical ingredient (API) manufacturer Nandu Chemicals Industries. In an inspection from 20 August, the French regulators uncovered significant deficiencies linked to “the vast majority of inspected areas” at Nandu’s Hubli, India site. In particular, the inspectors highli...

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Friday announced that it has put on hold the addition of Indian contract manufacturing organization (CMO) Akums Drugs' Haridwar-based site as a manufacturing facility for the marketing authorization of Nordic Pharma's hormone injection progesterone due to a lack of sterility assurance. An MHRA inspection of the site (its first inspection for the site) on 13 April revealed one critical and three major...

The Italian Medicines Agency on Wednesday released two statements of non-compliance with regard to good manufacturing practices (GMPs) for Visakhapatnam, India-based Krebs Biochemicals & Industries and Daund, India-based JP Laboratories. At the Krebs facility, the Italian regulators uncovered 24 deficiencies, five of which were classified as major. “The combination of the findings demonstrated a critical risk to public health, as the weaknesses of the company’s qua...

The European Medicines Agency (EMA) on Friday announced it is reviewing all EU-authorized drugs that relied on studies conducted by contract research organization (CRO) Semler Research after recent inspections uncovered serious data integrity violations at its Bangalore, India facility. EMA says it is conducting its review based on the issues raised by recent notices from the US Food and Drug Administration (FDA) and World Health Organization (WHO). According to EMA, th...

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) added Australia’s TFS Manufacturing to a list of medical device manufacturers that have not met device quality system requirements. TFS says it manufactures a tissue fixation system that “repairs organ prolapse by tensioning the ligaments and bringing laterally displaced connective tissue structures, such as ligaments and fascia, together. It combines soft tissue anchors with ...

Drug and biotech companies cannot replace pivotal clinical trials that are non-compliant with good clinical practice (GCP) standards during the assessment of marketing authorization applications, according to a new position paper from the European Medicines Agency (EMA). Stressing the importance of GCP compliance, the EMA says it’s an “essential prerequisite” for assessing a medicinal product’s safety and efficacy. The agency also clarifies that when a study is found to...

World Health Organization (WHO) inspectors earlier this week released a letter uncovering a number of safety issues at a Mumbai-based manufacturer of tuberculosis drugs. WHO said its inspection at the facility of Svizera Labs, which is part of Maneesh Pharmaceuticals, from June 2015 uncovered several critical and major deviations from WHO Good Manufacturing Practice standards and this latest Notice of Concern letter includes deficiencies that are still a problem for the ...

“Compliance” might be one of the most frequently-used terms in the healthcare industry. Compliance covers so many things and, in fact, is not merely a US issue. Life science companies must ensure global compliance, and this collection of feature articles in Regulatory Focus exclusively for RAPS members only scratches the surface. In “ Regulatory Quality Compliance Programs for Drugs and Biologics in the US and Canada ,” Ryan Thompson, Vadim Lysenko, Mukesh Kumar, Giri ...

Canada is looking to amend its Patented Medicines (Notice of Compliance) Regulations after two high-profile court rulings took a strict interpretation of the regulations that would make it more difficult to protect combination drugs under the regulations. Background In Canada, a notice of compliance is issued to a drug company when its product has been authorized. The requirements for a notice of compliance to be issued can be found in C.08.004 of the Food and D...

For one dietary supplement company warned by the US Food and Drug Administration (FDA) this week, regulatory compliance has something in common with what the company claims its "male enhancement" product will do to users: It's hard. Overview The Warning Letter—among the very few we've ever read to include explicit language—calls out Biogenix USA, a Mississippi- and Georgia-based company inspected by FDA in 2013. During the inspection, FDA said it collected "product labe...