The US Food and Drug Administration (FDA) on Monday released 53 product-specific guidance documents to aid generic drug development, including 34 new guidance documents, 26 guidances for treatments that lack generic competition and 16 for complex products. When finalized, the guidance documents will represent the current thinking of FDA on, among other things, the product-specific design of bioequivalence studies to support abbreviated new drug applications. Among th...

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday released four final guidance documents on the Special 510(k) program, the abbreviated 510(k) program, how to format traditional and abbreviated 510(k)s and CDRH’s refuse to accept policy for 510(k)s. As part of a wider, ongoing push to modernize FDA’s 510(k) program, the final guidance documents provide more clarity on several programs the agency has been working on...

As the US Food and Drug Administration (FDA) grapples with how to use real-world data for regulatory decisions, two FDA officials wrote in a perspective published last Friday in the Clinical Journal of the American Society of Nephrology that the agency is developing guidance on data quality issues unique to the real-world data setting and related study design considerations. Aliza Thompson and Mary Ross Southworth of the Division of Cardiovascular and Renal Products w...

Acting US Food and Drug Administration (FDA) Commissioner Ned Sharpless on Thursday announced that the agency would finalize guidance on developing treatments for amyotrophic lateral sclerosis (ALS) by the end of September. The 9-page draft guidance, first released in February 2018 , incorporated parts of a draft guidance put together by the ALS Association, known for its viral "ice bucket challenge," which FDA said provided the agency "with scientific advice and insig...

The question and answer (Q&A) document released by the European Medicines Agency (EMA) on Wednesday describes when an exemption from EU batch re-testing can be granted for imported advanced therapy medicinal products (ATMPs). The three-page Q&A begins by noting that a Qualified Person (QP) has to ensure each batch of imported ATMP is re-tested upon importation. But the QP can certify that the imported batch relies on controls conducted in a third country if the product ...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   India Seeks Feedback on Mandatory use of QR Codes on API Packaging   India is planning to require manufacturers to feature quick response (QR) codes on the packaging of locally made and imported active pharmaceutical ingredients (API). The Indian government plans to implement the system at the start of April.   Through an amendment to the Drugs and Cosmetics Rule...

The US Food and Drug Administration (FDA) on Wednesday added three new questions and answers to its Laboratory Controls questions and answers (Q&A) on Current Good Manufacturing Practices (CGMP) guidance. The new Q&As discuss instrument calibration standards for chromatographic systems, system suitability and trial injections.   On the issue of trial injections, where a sample of a lot is injected into the chromatographic system with the intention of obtaining an unoff...

The US Food and Drug Administration (FDA) on Tuesday updated draft guidance from July 2015 to address public comments and reflect the agency’s current thinking on the development of clinical outcome assessment measures and statistical considerations to assess primary and secondary efficacy endpoints of clinical trials for gastroparesis. The nine-page draft explains: “Until a well-defined and reliable PRO [patient-reported outcome] instrument that measures all the clinic...

The US Food and Drug Administration (FDA) on Wednesday released draft guidance to help sponsors establish the effectiveness and safety of gonadotropin-releasing hormone (GnRH) analogues for treating advanced prostate cancer.   GnRH agonists and antagonists are a mainstay for treating patients with prostate cancer, FDA says, noting that it is one of the most common forms of cancer in American men.   “New drug applications for GnRH analogues typically rely, in part, ...

As hormonal drugs to prevent pregnancy have evolved over the years, the US Food and Drug Administration (FDA) on Thursday drafted new guidance for drug developers on the recommendations for clinical trials designed to establish clinical effectiveness and safety for such products. In terms of key considerations for clinical trial design features, the six-page draft begins by explaining the recommended enrollment criteria for nonpregnant, premenopausal woman in trials, wh...

The US Food and Drug Administration (FDA) on Thursday released revised draft guidance to help keep sponsors informed on the data and model requirements for population pharmacokinetics (PK) analyses submitted as part of new drug applications and biologic license applications. Since the original population PK guidance was published in 1999, FDA says the number of applications relevant for population PK analysis has increased and, “The sophistication and reliability of pop...

While highlighting an updated version of the manufacturer incident report (MIR) form that will become mandatory in January 2020, the European Commission (EC) issued guidance Tuesday on the medical device vigilance system under the EU’s medical device directive.   The January version of the MIR introduces the use of the adverse event terminology/coding harmonized via the International Medical Device Regulators Forum (IMDRF) and the use of unique device identification (U...