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The time limitations defined in an FDA draft guidance on dispute resolution would place manufacturers at a disadvantage when using the system or result in dispute resolution requests that are incomplete, according to PhRMA.
OTC drugmaker Almil Nutritional Products has been issued an FDA warning letter outlining 12 good manufacturing practice (GMP) deficiencies found by investigators during an inspection of its Brea, Calif., manufacturing facility.
Devicemakers need to provide the FDA with statistics to back up the number of process validation runs they choose to do on products under review to prove that the number was appropriate, according to an FDA official.
Devicemakers do not have to substantially revise ISO 13485-compliant quality management systems (QMS) to meet the FDA's quality system regulation (QSR) because the standard does not set up conflicting requirements, according to David Feigal, director of the Center for Devices and Radiological Health (CDRH).
Drugmakers who disagree with FDA inspectors on scientific and technical questions during a current Good Manufacturing Practice (cGMP) inspection can now take advantage of a year long dispute resolution pilot program.
Drugmakers should assess the powder mix uniformity of their raw materials and correlate this data with stratified in-process dosage unit data and finished product samples before implementing manufacturing control methods on their products, the FDA recommended in a new draft guidance.
Eli Lilly has resolved FDA concerns about current GMP issues at its Indianapolis facilities, where it plans to manufacture the antidepressant Cymbalta and injectable schizophrenia drug Zyprexa, the company announced recently.
Drug companies do not have to include stability data on undistributed reprocessed batches that are not typical of batches produced by the approved manufacturing process in annual reports to the FDA, according to the Division of Manufacturing and Product Quality (DMPQ).
The FDA has revised storage stability testing of new drug substances and products, and products packaged in semipermeable containers, to accommodate climates that have higher humidity, the agency announced in a pair of revised guidances that went into effect in late November.
The FDA should allow for reporting categories other than Prior Approval Supplements (PASs) for comparability protocols if tests and studies do not meet predefined acceptance criteria, PhRMA told the agency in comments on a draft guidance on the protocols.