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Hospira conducted its fourth recall in roughly two months due to contaminated products, leading to another quality headache for the injectables giant. Read More
The FDA asked healthcare professionals to watch out for drugs compounded by a Dallas-based pharmacy after a recent inspection revealed 22 lots of sterile drugs failed quality tests. Read More
The FDA has stepped up its enforcement of compounding pharmacy quality violations that occurred before a new law took effect that boosted agency powers, a move that some industry players contend is unjust. Read More
OTC drugmaker P&L Development received a Form 483 after investigators found the company didn’t test certain products for yeast and mold before release and for poor data integrity. Read More
An active pharmaceutical ingredient (API) maker was chided by the FDA for not keeping batch records, as well as not investigating out-of-specification results or performing full testing on products. Read More
A slew of leaky, deteriorating products, an insect infestation and poor complaint handling resulted in another Form 483 for beleaguered injectables giant Hospira. Read More
The new rule establishing FDA powers to destroy suspected counterfeit and adulterated drugs could cause shortages if the agency doesn’t protect against officials destroying needed excipients that get caught up in an import dispute, according to PhRMA. Read More
Over the next five years the FDA plans to increasingly coordinate its inspections and enforcement activities with its international counterparts. Read More
The FDA intends to step up its scrutiny of a company’s data integrity protections during manufacturing inspections, following a series of investigations that caught drugmakers backdating manufacturing records and falsifying data. Read More
The FDA will grant marketing exclusivity only to biologics that are fundamentally different from existing products, according to a new guidance that explains what manufacturers must do to lock in protection from biosmiliar competition. Read More