Quality Systems

The US Food and Drug Administration's New Jersey District Office issued a Warning Letter to Concord Laboratories (Fairfield, NJ), citing the company for manufacturing three generic products without an ANDA, and for ten deviations from current good manufacturing practices.

The US Food and Drug Administration (Rockville, MD) has sent warning letters to RoTech Healthcare, Inc. (Orlando, FL), CCS Medical (Clearwater, FL), and Reliant Pharmacy Services (Clearwater, FL), demanding that they stop manufacturing and distributing compounded, unapproved respiratory drugs.

On Oct. 10, the US Food and Drug Administration (Rockville, MD) will hold a public meeting on products containing nanotechnology materials.

The US Food and Drug Administration has opened the FDA Electronic Submissions Gateway (ESG) to receive and process regulatory submissions to the Center For Biologics Evaluation and Research, the Center for Drug Evaluation and Research, and the Center for Devices and Radiological Health.

The US Food and Drug Administration has published a draft guidance, Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria (RAAPAC).

Schering AG (Berlin, Germany) voluntarily issued a worldwide recall of all lots of its X-ray contrast agent "Ultravist Injection" 370 mgI/mL (iopromide injection) because particulate matter and crystallization may be present in the product.

The US Food and Drug Administration announced its Prescription Drug User Fee Amendments of 2002 (PDUFA II) fees schedule for fiscal year 2007 (Oct. 1, 2006 - Sept. 30, 2007), including increases ranging from 17% to 19%.

Disappointed in progress thus far, the US Food and Drug Administration wants pharmaceutical manufacturers to make a greater effort to combat counterfeit products and recommends that they "move quickly" to implement radio-frequency identification technology.

Thanks to you, we have this month's column. Keep those cards, letters, and e-mails coming.

Ranbaxy issued three responses (March 20, April 20, May 25) to FDA's Form 483.

The new drug user-fee program will define how FDA does business over its next 100 years.

The UK Medicines and Healthcare Products Regulatory Agency (MHRA, London) has reissued its recall of a specific batch of counterfeit ?Lipitor? 20-mg tablets. MHRA, in conjunction with Pfizer (New York City, NY), first issued the recall of batch number 004405K1 in July 2005. The new recall is in response to the discovery of more packages of the counterfeit drug in the United Kingdom.

Roxane Laboratories (Columbus, OH), a Boehringer Ingelheim company, is conducting a voluntary recall in the United States and Puerto Rico of a single manufacturing lot of "Azathioprine"tablets, USP 50 mg.

On July 18, the US Food and Drug Administration posted a Warning Letter issued Watson Laboratories Caribe, Inc. (Corona, CA) by FDA's San Juan (PR) district office.

The US Food and Drug Administration today posted its final "Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format: Lot Release Protocols."

The US Food and Drug Administration (Rockville, MD) announced that Baxter Healthcare Corp. (Deerfield, IL) signed a consent decree relating to the company's "Colleague" volumetric infusion pump and "Syndeo" patient-controlled analgesic syringe pump.

Vaccine maker Sanofi Pasteur, Inc. received a US Food and Drug Administration Warning Letter, dated June 30, citing "significant deviations" from current good manufacturing practices in the production of monovalent concentrates used in the company?s ?Fluzone? influenza vaccine.

FDA is conducting laboratory research to understand better the ability of preclinical screening tests to identify potential risks and toxicities of nanotechnology-based drugs.

Pharmaceutical Science & Technology News

My audit host clearly knew and lied about the planned changes.

The US Food and Drug Administration (Rockville, MD) is restructuring its Office of Regulatory Affairs (ORA) into two offices.

On June 15, 2006, the US Food and Drug Evaluation?s Center for Drug Evaluation and Research (Rockville, MD) issued a 7-page warning letter to Ranbaxy Laboratories (Himachal Pradesh, India) for violations to US current good manufacturing practices.

Coinciding with the 100th anniversary of the US Food and Drug Administration (Rockville, MD), Representative Henry A. Waxman (D-CA) released a statement this week expressing his concern over ?an agency that is adrift and floundering.?

This week, the US Food and Drug Administration (Rockville, MD) posted a Warning Letter issued May 31 by its New Jersey District Office (Parsippany, NJ) to Neil Laboratories (East Windsor, NJ) for CGMP deviations.

Microsoft Corporation (Redmond, WA) announced the winners of the Microsoft Pharmaceuticals and Life Sciences Innovation Awards 2006 at this year?s meeting of the Drug Information Association in Philadelphia, Pennsylvania. A four-person panel of industry experts selected winners for the innovative use of Microsoft products in pharmaceutical and life sciences business processes and practices.

This week?s PharmTech Annual Event (www.pharmtechevent.com) in Somerset, New Jersey, targeted approaches to improving drug development and quality through optimizing processes, managing risk, and controlling variations in manufacturing operations.

The US Food and Drug Administration?s Counterfeit Drug Task Force (Rockville, MD, www.fda.gov) is recommending regulatory actions and the implementation of new technologies for reducing the risk of counterfeit drugs entering the United States. The group has followed up on its original 2004 report, in which it outlined the framework for protecting the public from counterfeit medicines, and an updated 2005 report with a third document encouraging electronic pedigrees, improved traceability in the drug supply chain, and the adoption of radio-frequency identification (RFID) tools.

Noting several violations in current good manufacturing practice regulations, the US Food and Drug Administration has issued a Warning Letter to Wyeth Pharmaceuticals?s (Collegville, PA) manufacturing facility in Puerto Rico.

China?s State Food and Drug Administration (SFDA, Beijing, China) issued a notice on May 18, 2006, requiring drug regulatory departments of provinces, autonomous regions, and municipalities to further strengthen the supervision and management of drug manufacturers.

The US Food and Drug Administration (Rockville, MD) is withdrawing seven guidance documents "because some of the principles in these guidances are inconsistent with the agency's initiative, Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century (CGMP Initiative) .