Chronic regulatory lapses at manufacturing facilities are exacerbating drug shortages and patient safety issues, claims a new report published in The New York Times . The report chronicles the huge number of issues-some of them particularly egregious-that have occurred in recent years at facilities responsible for manufacturing pharmaceutical products. The problem is especially prominent at facilities that manufacture sterile injectable drugs, which have experienced...

Taiwan is preparing to join the Pharmaceutical Inspection Convention and Cooperation Scheme (PIC/S) in 2013, vaulting ahead of several other Asian countries preparing to do the same, reports Taiwan Today . PIC/S is an informal arrangement between consenting health regulatory authorities to exchange information, and chiefly works to promote the quality of pharmaceutical products. The organization is made up of two distinct parts which are different in regard to the...

Taiwan is preparing to join the Pharmaceutical Inspection Convention and Cooperation Scheme (PIC/S) in 2013, vaulting ahead of several other Asian countries preparing to do the same, reports Taiwan Today . PIC/S is an informal arrangement between consenting health regulatory authorities to exchange information, and chiefly works to promote the quality of pharmaceutical products. The organization is made up of two distinct parts which are different in regard to the...

The US Food and Drug Administration (FDA) is laying the groundwork to eventually transition away from the use of paper-based inspection journals in favor of digital-based tablet inspection aids, say several FDA officials. The agency, including FDA Commissioner Margaret Hamburg, has recently begun to tout its use of a new, Windows-based rugged tablet computer for use during egg  farm inspections. An FDA spokeswoman, Patricia El-Hinnawy, told Regulatory Focus that ...

Regulators at the European Medicines Agency (EMA) have released the results of an assessment undertaken after an inspection of California-based Pacira Pharmaceuticals uncovered good manufacturing practice violations and sterility issues. The assessment pertains to a single drug, DepoCyte (cytarabine), used to treat patients with lymphomatous meningitis, a rare peripheral cancer affecting the spinal cord and brain tissue. EMA officials said they had inspected Pacira'...

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...

China's State Food and Drug Administration (SFDA) has launched a new medical device manufacturing inspection program for the Provinces and Municipalities to implement during an inspection of a medical device manufacturing site.  The inspection program's 15 articles require local regulatory authorities to undertake a number of measures, such as a follow-up inspection in cases where serious flaws are uncovered and ensuring that the company has established a quality...

In the long list of things that are inadvisable to regulatory professionals, making misleading statements to the authority in charge of regulating your business likely ranks near the top. Those found to have misled the US Food and Drug Administration (FDA) have in the past been publicly warned, fined, imprisoned, shut down and barred from participating in federal programs. Now KV Pharmaceuticals is facing the prospect of an additional action: a class-action shareholder l...

The US Food and Drug Administration (FDA) has released new guidance on how small medical device companies can qualify as an FDA-approved small business and be eligible to pay reduced fees under the Medical Device User Fee Act (MDUFA) . FDA's Guidance for Industry and FDA Staff and Foreign Governments: FY 2012 Medical Device User Fee - Small Business Qualification and Certification  notes small businesses are authorized to pay "substantially reduced" fees under t...

The US Food and Drug Administration (FDA) fired off numerous warning letters to dietary supplement manufacturers this week. While its actions against ten manufacturers of dimethylamylamine (DMAA) garnered significant attention , FDA also sent warning letters to six other dietary supplement manufacturers for allegedly violating numerous regulations under the Federal Food, Drug and Cosmetic Act (FDCA) . Manufacturer Vitality Distributing, Inc.,  received an FDA warn...

The US Food and Drug Administration (FDA) moved on 23 April to notify pharmaceutical companies who had contracted out bioanlytical studies to contract research organization Cetero, which FDA has accused of conducting falsified studies. The agency conducted inspections of Cetero's Houston, Texas-based facilities twice in 2010, and "identified significant instances of misconduct and violations of federal regulations, including falsification of documents and manipulation of...

The Korean Food and Drug Administration (KFDA) and Japan's Pharmaceutical and Medical Device Agency (PMDA) have applied for membership in the Pharmaceutical Inspection Co-operation Scheme (PIC/S), the groups reported. PIC/S is an informal arrangement between consenting health regulatory authorities to exchange information, and has been hailed as a "global leader in helping to ensure the quality of drugs" by US Food and Drug Administration Commissioner Margaret Hamburg....