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    FDA draft guidance addresses clinical development of drugs to treat early Lyme disease

    The US Food and Drug Administration (FDA) Center for Drug Evaluation Research (CDER) has issued a draft guidance to help sponsors develop new drugs to treat the early stages of Lyme disease.   The draft addresses criteria for clinical trial enrollment, efficacy endpoints, and clinical microbiology considerations for treating early stages of the disease when manifested by erythema migrans (EM), a rash that is often one of the first symptoms.   In North America, Lyme...
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    FDA draft guidance addresses use of external controls to assess effectiveness of new drugs and biologics

    The FDA Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) have issued draft guidance describing sponsors can leverage external controls, such as use data from registries and electronic health records, in lieu of data from randomized controlled trials (RCTs) to demonstrate the safety and effectiveness of new drugs and biologics.   The draft guidance also describes how sponsors can communicate with FDA on using dat...
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    FDA releases FY 2022 generic drug research summary

    The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) on Tuesday released a report summarizing its research activities in fiscal year 2022 in 13 different scientific areas under the Generic Drug User Fee Amendments (GDUFA III).   The research generated from the program enabled FDA to issue 177 new and revised product-specific guidances (PSGs), 59 of which were for complex products, according to the summary.   “The recommendations in many of th...
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    Subpart H and the implications for ad promo

    Advertising and promotion (ad promo) of prescription drugs is regulated by the US Food and Drug Administration (FDA). In 1992, the agency implemented Subpart H of Title 21 of the Code of Federal Regulations (CFR) to allow for the accelerated approval of new drugs for serious or life-threatening illnesses. Approval of a drug through the Subpart H pathway introduced a range of regulatory requirements, some of which had specific implications for the ad promo of Subpart H drug...
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    FDA issues draft guidance on developing drugs for acromegaly

    The US Food and Drug Administration (FDA) has issued a draft guidance to assist sponsors develop acromegaly treatments for patients who have either not responded to surgery or are in poor health.   Acromegaly is a chronic, rare disease in adults caused by excess growth hormone that can cause enlarged hands and feet, among other symptoms. The most common cause stems from a growth hormone that stimulates hepatic overproduction of insulin-like growth factor-1 (IGF-1).  ...
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    FDA announces FY 2023-2027 BsUFA science and research priorities

    The US Food and Drug Administration (FDA) on Thursday released a roadmap on its science and research priorities for fiscal years 2023-2027 to spur the development of biosimilars and interchangeable products.   Under the Biosimilar User Fee Amendments (BsuFA) III program, FDA has offered $5 million in funding for several research proposals under the regulatory science pilot program (RELATED: FDA offers funding for biosimilar regulatory science pilot , Regulatory Foc...
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    FDA officials impart lessons learned from quality management maturity pilots

    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...
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    FDA details approach for finding optimal dosages for new cancer drugs

    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...
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    Budget law calls for BARDA and FDA to establish “warm base” manufacturing to better prepare for future pandemics

    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...
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    FDA issues draft guidance on dosage and administration labeling

    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...
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    Omnibus spending bill expands FDA’s unannounced foreign inspections pilot

    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 ...
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    FDA cites Sun Pharma with litany of GMP violations, including poor aseptic practices

    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...