Drugs
The Product Quality Research Institute (PQRI) is set to host a critical conference in September, where the first major dispute between FDA and the regulated industry over blend uniformity analysis (BUA) will take center stage. The August 1999 draft guidance on BUA has triggered concerns among industry stakeholders, who fear
Drugs
Abbott Labs, a well-established pharmaceutical firm, has once again drawn the attention of FDA investigators with a warning letter issued on July 3. This time, the scrutiny is focused on the company's North Chicago facility, where inspectors found issues with sterilizer filter validation studies and product testing procedures
Pharmaceutical industry
SmithKline Beecham, the manufacturer of the diabetes medication Avandia (rosiglitazone maleate), has issued a statement defending the drug against criticism from the U.S. Food and Drug Administration (FDA) and other regulatory agencies. The statement, made by David Wheadon, MD, director of Regulatory Affairs - North America, at the FDA
Pharmaceutical industry
The US FDA's Center for Food Safety and Applied Nutrition (CFSAN) is struggling with a space shortage due to unexpected growth in staff. The new College Park, Md., facility will be smaller than the existing C Street building, requiring around 170 offices and labs to be housed in
Drugs
Chesapeake Biological Laboratories, Inc., a Baltimore-based pharmaceutical and medical device developer, has announced that one of its clients has received FDA approval for commercial manufacturing. Additionally, a second client has received a FDA approvable letter, signifying the final step before FDA clearance for marketing in the United States. The third
Drugs
The US FDA has released several updates to its regulations and guidance documents in recent months, covering various areas including over-the-counter human drugs, biologics, and medical devices. The updates aim to improve compliance, enhance safety, and provide clarity to industry stakeholders. The Federal Register, a government publication, lists the issue
Pharmaceutical industry
The Food and Drug Administration (FDA) has issued a warning to KV Pharmaceutical Co., a St. Louis-based drug manufacturer, for unacceptable quality control practices at several of its facilities. The FDA inspectors detected improper data reporting, the use of raw materials of questionable quality, and contamination of a vaginal anti-fungal
Pharmaceutical industry
Teva Pharmaceutical Industries Ltd., a leading generic pharmaceutical company, has received final approval from the US FDA to manufacture and market Nabumetone 500 mg Tablets, the generic version of the SmithKline Beecham drug Relafen(R), for the treatment of acute and chronic osteoarthritis and rheumatoid arthritis. With 180 days of
Pharmaceutical industry
The FDA's inspection of Allergan's facility in Hormigueros, Puerto Rico, resulted in a warning letter and regulatory documentation. The inspection was conducted from November 3 to December 22, 1998. Investigator Luis Soto-Lopez identified several deficiencies, including stability test failures, failure to submit field alert reports, and
Drugs
In a span of nearly four months, from March to July 1999, Marsam Pharmaceuticals, a subsidiary of Schein Pharmaceuticals, was inspected by the New Jersey District Investigators Denise DiGiulio, Joseph McGinnis, and Regina Brown, along with chemist Jean Blackston-Hill. The inspection revealed numerous discrepancies and critical issues, leading to a
Pharmaceutical industry
A significant milestone has been reached in the fight against HIV as Bristol-Myers Squibb Co. has announced that the US FDA has granted a priority review for Videx capsules, a new medication that promises to simplify treatment regimens and reduce side effects. If approved, Videx capsules will be the first
Drugs
DUSA Pharmaceuticals, Inc., a biopharmaceutical company, has filed a Pre-Market Approval (PMA) Supplement with the FDA for the commercial version of its BLU-U(TM) brand light source. This move follows the FDA's approval of the Company's Levulan(R) Kerastick(TM) 20% topical solution PDT of the
