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After the FDA warned Tiara Medical Systems for several current good manufacturing practice violations regarding its complaint handling system, the company successfully responded to all charges, the agency said.
The Australian Therapeutic Goods Administration (TGA) has released revised guidance on good manufacturing practice (GMP) requirements for foreign drugmakers seeking to register their products in the country, as well as overseas makers of active pharmaceutical ingredients (APIs).
Ongoing upgrading of medical device legislation is common in Asian countries, according to Carolyn Albertson, director of international regulatory affairs for Abbott Laboratories. Read More
Miltronics & Skye violated several current good manufacturing practice (cGMP) regulations in making its implantable orthopedic devices, according to an FDA warning letter. Read More
A U.S. appeals court has upheld a lower court’s ruling maintaining the 180-day marketing exclusivity period for generic drugmakers Ranbaxy Laboratories and Teva Pharmaceutical to market their versions of Merck’s Zocor, a cholesterol treatment drug that generated nearly $4.5 billion in sales for the brand company last year.
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The FDA intends to issue a proposed rule on current good manufacturing practices (cGMPs) for combination products next spring, a senior FDA official said at the Regulatory Affairs Professionals Society annual conference last month.
In an effort to help pharmaceutical manufacturers evaluate test results, the FDA is issuing a new guidance on investigating out-of-specification (OOS) results that fall outside the acceptance criteria established in drug applications, drug master files, official compendia or by the manufacturer.
The intercenter agreements (ICAs) governing how combination and single-entity products are assigned to FDA centers have become incomplete statements due to a slew of emerging products and the large volume of jurisdictional decisions the agency has made in recent years, the FDA said.
In an effort to help biologic product manufacturers report deviations from current good manufacturing practices (cGMPs), the FDA issued a guidance detailing the correct steps to take when an event occurs that may affect the safety, purity or potency of products.
Device and drug manufacturers should not take the somewhat vague language in federal regulations to mean they can get away with perfunctory, "checklist"-style GMP training, according to an expert speaking at a recent FDAnews audioconference.