The US Food and Drug Administration’s (FDA) should brief pilot participants ahead of the actual assessments and use a simplified rubric for scoring or rating a manufacturers quality management maturity (QMM) program. These were some of the lessons learned as the agency develops a future rating program for evaluating manufacturers on drug quality, according to results reported in a 10 January article published in The AAPS Journal .   These pilots “afforded FDA the opp...

The US Food and Drug Administration (FDA) has issued a draft guidance to help sponsors identify the optimal dosage for cancer drugs in clinical development and in it, the agency recommends a new approach in selecting such dosages for modern, targeted oncology drugs.   Historically, dose-finding trials for cytotoxic chemotherapy drugs have been designed to determine the maximum tolerated dose (MTD). The MTD paradigm applies to drugs that have a steep dose-response, have...

The federal budget law passed by Congress and signed by the president in late December calls on federal authorities to establish “warm base” domestic manufacturing to respond quickly to demand surges for medical products during a public health emergency.   Section 2401 of the law calls on the Biomedical Advanced Research and Development Authority (BARDA) to work with the US Food and Drug Administration (FDA) to coordinate these efforts.   The law amends Section 319...

The US Food and Drug Administration (FDA) has issued draft guidance aimed at improving the consistency of information in the dosage and administration section of prescription drug labeling. Such consistency will ensure that labeling is “pertinent and understandable” to health care practitioners, said the agency.   The draft is a wholesale rewrite of an earlier guidance issued in March 2010, which has now been withdrawn. The new guidance, which is roughly triple the l...

The recently enacted omnibus spending bill approved by Congress in late December directs the US Food and Drug Administration (FDA) to expand its unannounced foreign facility inspection pilot program in a quest to achieve parity with domestic inspections, which are mostly unannounced.   The FY 2023 spending bill was signed by President Biden on 27 December. The bill authorizes $3.5 billion in budget authority for FDA in FY 2023, a 6.5% increase compared to the previous ...

The US Food and Drug Administration (FDA) admonished Sun Pharmaceutical Industries in a recent warning letter for a several good manufacturing practice (GMP) violations, including poor aseptic practices, inadequate cleanroom design and environmental monitoring and failure to keep manufacturing equipment clean.   These violations prompted FDA to place the firm on import alert on 7 December.   FDA inspected the firm’s Gujarat India facility from 26 April to 9 May 202...

A pharmaceutical trade group and several drugmakers urged the US Food and Drug Administration (FDA) to take a more flexible approach in its guidance on pediatric measurements in clinical trials and questioned whether 12 months is sufficient to provide meaningful information for growth and development.   These comments were made in response to the agency’s call for feedback on the draft guidance, which outlines ways sponsors can measure pediatric growth consistently in ...

The US Food and Drug Administration (FDA) on Wednesday finalized guidance outlining its expectations for the format and content of a risk evaluation and mitigation strategy (REMS) document for certain high-risk prescription drugs and biologics that pose safety concerns and incorporates “extensive” stakeholder feedback, said the agency.   The draft version of the guidance was first issued for comment in 2017. (RELATED: REMS Format and Content: FDA Offers Draft Guidanc...

The US Food and Drug Administration (FDA) on Wednesday issued a draft guidance to assist generic drug manufacturers in requesting information from the agency through the controlled correspondence process. The guidance reflects the changes that were part of the reauthorization of the Generic Drug User Fee Amendments (GDUFA III) and expands the topics that are eligible for controlled correspondence as compared to previous iterations of the program.   The GDUFA III comm...

The US Food and Drug Administration’s (FDA) has issued draft guidance proposing that devices be deemed adulterated and refused entry to the US market if companies refuse to allow inspections of their facilities without adequate justification. Under current FDA policy, only drugs can be deemed adulterated if FDA inspectors are barred at the door.   The draft align with an update in the law under the FDA Reauthorization Act (FDARA), which requires devices also be dee...

Updated 12 December to reflect correct acronym for FDA's Office of Compliance* A top official with the US Food and Drug Administration’s (FDA) Office of Compliance (OC) reflected on some of the top trends that drove the agency’s compliance actions in 2022 at the Food and Drug Law Institute’s (FDLI) annual enforcement meeting on 7 November.   “Adverse events and safety issues drive our work,” said Jill Furman, acting director of FDA's Center for Drug Evaluation an...

The US Food and Drug Administration (FDA) recently sent an untitled letter to Connecticut-based contract testing lab Valisure for failing to comply with the Drug Supply Chain Security Act (DSCSA) and for findings of “methodological deficiencies” in the company’s analytical testing laboratory.   FDA’s action targets a company that played a role in several recent high-profile recalls after it raised concerns about the levels of possible carcinogenic impurities found in...