• FDA Transitioning to Tablet-Based Inspection System for Food, Pharmaceutical Facilities

    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 ...
  • EMA Warns of Potentially Contaminated Cancer Drug in Light of Manufacturing Deficiencies

    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'...
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    The Problem with Audit Reports

    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: SFDA Launches New Device Compliance Program

    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...
  • Judge: Regulatory Inspection Report Can Form Basis of Class Action Lawsuit

    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...
  • FDA Releases Guidance on How to Qualify for Small Business User Fee Waivers

    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...
  • Six Dietary Supplement Manufacturers Cited by FDA for Promoting Unproven Claims, CGMP Violations

    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...
  • FDA: Companies Who Dealt With Cetero Must Repeat or Confirm Some Bioanalytical Studies

    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...
  • Korea, Japan Apply for PIC/S Membership

    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....
  • FDA: After Recall of 300M Wipes, New York Manufacturer Still Failed to Test Products

    A report issued by the US Food and Drug Administration (FDA) is faulting a New York-based company for failing to test its sterile wipe products even after recalling hundreds of millions of products due to bacterial contamination, reports The Bellingham Herald. The company, Professional Disposables Incorporated, initiated a recall in September 2011 involving 300 million alcohol pads which were supposed to be sterile but were instead contaminated with Bacillus cerus. Tha...
  • Joint FDA, Chinese Training Helping to Boost Product Safety

    The US Food and Drug Administration (FDA) announced it has trained more than 1,600 regulatory professionals in China on US safety standards, which It says is helping to develop an "infrastructure that better ensures product safety." In its 5 April website posting, FDA's China Offices Focus on Product Safety , FDA notes their 13-person staff in China "represents a new era in cooperation between the United States and China on the safety of food and medical products." "...
  • IOM: Boost Foreign Regulatory Capacity to Ensure Drug Safety

    A new report from the Institute of Medicine (IOM) concludes the US Food and Drug Administration (FDA) needs to make investments into advancing the regulatory capacity of developing low- and middle-income nations in order to secure the pharmaceutical supply chain and safeguard the American public. The report, Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad , recommends 13 steps FDA and other regulatory bodies can take in the next five ...