The pharmaceutical industry would like to get more clarity on the timing of drug-drug interaction (DDI) studies and the scope of these DDI studies in their comments to regulators on the proposed International Council for Harmonization’s (ICH) M12 guideline, said a regulator at an ICH regional meeting sponsored by the US Food and Drug Administration (FDA) and Health Canada on 24 February.   Rajanikanth Madabushi, associate director for guidance and scientific policy at ...

Two US pharmaceutical industry groups note that they are generally supportive of the International Council for Harmonization (ICH) guideline on pediatric extrapolation in drug development but suggest that the guidance should address a broader subset of the population and not just focus on extrapolating data from adults. The groups called for more information on using biomarkers for the pediatric population and for including the estimands concept in the final guidance.   ...

The pharmaceutical industry would like the International Council for Harmonization (ICH) to clarify dosing information for rifampin and requests additional information on the use of biomarkers as a type of drug-drug interaction study (DDI), while the Pharmaceutical Research and Manufacturers of America (PhRMA) and Pfizer want more flexibility in developing a DDI strategy.   The comments were made in response to the US Food and Drug Administration’s (FDA) call for feedb...

The International Council for Harmonisation (ICH) recently announced that its S1B(R1) addendum outlining a “weight of evidence” (WoE) approach to assess the human carcinogenic risk for certain pharmaceuticals in lieu of conducting a two-year rat study has reached Step 4 and is awaiting sign-off by regulators.   The document contains several changes from the Step 2 guideline released in May 2021. (RELATED: To speed drug development, ICH proposes reducing rat carcinoge...

The US Food and Drug Administration (FDA) found a slew of good laboratory practice (GLP) violations during the conduct of nonclinical studies at West Sacramento, CA firm Valley Biosystems in a 3 August warning letter and blasted the firm for not following its own procedures governing animal welfare, inadequate staff training, data integrity issues and inadequate reporting of nonclinical studies.   The warning letter was sent to the West Sacramento, CA, based firm ove...

The pharmaceutical industry is calling for changes to the US Food and Drug Administration’s (FDA) draft guidance on radiolabeled mass balance studies, suggesting the guidance be revised to require fewer subjects, and mention a male preference for these studies, with exceptions for females of non-child-bearing age. One manufacturer recommended that antibody drug conjugates (ADCs) be excluded from these studies.   The comments were submitted in response to FDA’s draft ...

Feature articles in June examined food safety in China, US Food and Drug Administration (FDA) guidance on supply chain disruptions, possible updates to the US Dietary Supplement Health and Education Act (DSHEA), and FDA and Federal Trade Commission (FTC) regulation of dietary supplements intended for treating or preventing certain mental health disorders.   Safety, disruptions, and responsive policy  China has improved its overall food safety situation significant...

The US Food and Drug Administration (FDA) recently issued two guidances for industry: a final guidance on how to conduct food effect studies for oral drugs being considered for investigational new drug (IND) and new drug applications (NDAs), and a draft guidance outlining a current good manufacturing practice (CGMP) framework for preventing penicillin from cross contaminating non-penicillin beta-lactam drugs and compounds. Food effect studies   The final guidance on...

Two industry trade associations and a pharmaceutical company are asking for some adjustments and clarification on the US Food and Drug Administration’s (FDA’s) draft guidance on safety reporting or investigational drugs and devices. The comment period on the guidance closed at the end of November.   FDA’s draft guidance includes details of how the agency believes investigators should report serious and non-serious adverse events in investigational new drug applicatio...

The article compares and contrasts the regulatory requirements for herbal medicinal products (HMPs), herbal-based medical devices and botanical food supplements in the EU. It is part 2 of a two-part article – Part 1 presented the definitions, main regulations, and documentation requirements for placing the products on the market; Part 2 will address quality, the strength of evidence supporting the safety and efficacy, and postmarket surveillance (PMS) requirements across...

Most of the 55 guidelines from the International Council on Harmonisation that relate to quality, safety and efficacy, as well as multidisciplinary guidelines, have been adopted among its 10 non-founding members and observers and 30 pharmaceutical companies, according to the results of a new survey.   The survey was designed to monitor the adequacy and level of implementation to ICH guidelines by regulators and industry and complements one released in 2019 on the adopt...

The US Food and Drug Administration (FDA) imposed a boxed warning on the labeling of rubidium 82 generators, which are used with Positron Emission Tomography (PET) heart perfusion imaging scans. The agency circulated the drug safety alert on Monday in response to recent excess radiation exposure incidents. Manufacturers Bracco Diagnostics and Jubilant DraxImage also sent letters last month to inform health care providers about incidents of patients’ exposure to high lev...