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The FDA is telling drugmakers not to file supplemental applications for minor postapproval manufacturing changes such as swapping excipient suppliers, moving a manufacturing process within a plant or removing coloring or flavoring ingredients from a drug. Read More
Sponsors planning on sending lot release samples to CBER in May and June should plan to delay until after the center relocates to the FDA’s White Oak headquarters in Silver Spring, Md. Read More
Ben Venue is working with the FDA on a recall of its acetylcysteine solution 10 percent USP after a single glass particle was found in just one vial of a lot of the drug, the company said last month. Read More
University of Iowa Pharmaceuticals, a contract manufacturer affiliated with the school, received a Form 483 for deficient training materials and poor investigations into quality issues. Read More
The FDA handed distributor and positron emission tomography (PET) drugmaker Cardinal Health a Form 483 for failing to properly verify batch records. Read More
Concerns with particulates in injectable drugs are plaguing Agila Specialties again as the Mylan unit revealed last month that its Polish plant is at the center of a recall of an anesthetic product. Read More
India will no longer allow the importation of drugs that have used up more than 40 percent of their shelf life, India’s Central Drugs Standard Control Organization (CDSCO) said last month. Read More
The FDA will create a pharma-only enforcement unit that promises more consistent inspections and enforcement decisions with fewer bureaucratic hurdles for investigators to issue warning letters. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MRHA) is reminding drugmakers they must report all defects in medicinal products that could lead to a recall immediately upon discovery and provide regular updates on internal investigations into the defects. Read More
The HHS Office of Inspector General (OIG) this year plans to analyze the findings from FDA inspections of generic drugmakers’ facilities to determine the effectiveness of inspections on ensuring the quality of generic medicines. Read More
Government auditors last month criticized the FDA for its ongoing drug shortages problem, while House lawmakers chastised the agency at a hearing for not taking more action. Read More