Evidence does not support the clinical utility of compounded bioidentical hormone therapies and their use should be limited to patients who cannot use products approved by the US Food and Drug Administration (FDA), according to a consensus study report from the National Academies of Science, Engineering and Medicine (NASEM).   FDA requested the NASEM review due to increasing popularity of compounded bioidentical hormone therapies (cBHT) combined with concerns over he...

The biopharma industry is urging the European Union to separate talks about post-Brexit regulatory cooperation from broader political negotiations. Groups including the European Federation of Pharmaceutical Industries and Associations (EFPIA) made the plea amid fears the collapse of free trade talks will force a hard split between the United Kingdom and EU regulatory regimes.   In a letter to senior EU officials, the six trade groups call for Brexit negotiators to pr...

Consumers reading a model drug facts label for naloxone could understand labeling sufficiently to use the opioid antagonist safely and effectively without the support of a healthcare provider, according to a label-comprehension study conducted by the US Food and Drug Administration (FDA).   The unusual move by the FDA could help clear a hurdle to approval of over-the-counter injectable and intranasal naloxone; many public health experts concerned about the impact of th...

The US Food and Drug Administration (FDA) has developed a standard memorandum of understanding (MOU) with the states that addresses interstate distribution of compounded drugs.   Under the MOU , expected to be signed by 45 states, pharmacy compounders that distribute more than 50% of their compounded drug products interstate will be identified by the states. States will be required to report certain information about these compounders to the FDA.   The 50% thresho...

The World Health Organization (WHO) this month issued guidance detailing its expectations and flexibilities during the coronavirus (COVID-19) pandemic for manufacturers, laboratories and contract research organizations taking part in the agency's prequalifications programs. Localized adjustments in processes and procedures may be necessary for manufacturing, clinical trial and testing organizations due to the coronavirus pandemic, but should aim to minimize the risk of ...

This case study explains Project BRIDGE and its vision to centralize process and services, such as dossier planning, compilation and publishing, submission, tracking and archiving to efficiently ensure compliance, increase transparency and maintain or improve quality of submissions to global health authorities. Introduction The author began employment at Boehringer Ingelheim, a large global pharmaceutical company with headquarters in Germany in October 2014. At that ti...

The US Food and Drug Administration (FDA) on Friday warned against the use of malaria drugs hydroxychloroquine and chloroquine to treat coronavirus disease (COVID-19) outside hospitals or clinical trials due to serious heart risks.   FDA says it is “aware of reports of serious heart rhythm problems,” including deaths in COVID-19 patients treated with the drugs, either alone or in combination with other QT-prolonging drugs such as azithromycin, and warns that patients w...

The proportion of drugs approved by the US Food and Drug Administration (FDA) on the strength of two or more pivotal trials fell by almost 30 percentage points over the past 20 years, according to an analysis published in JAMA Network Open.   Guidance from the late 1980s, when FDA set down its thinking on the data needed to win approval, indicate that at least two late-phase clinical trials were needed. However, FDA has long deviated from that standard in situations – ...

Increasing demand for sedatives used to help put COVID-19 patients onto ventilators means the US Food and Drug Administration (FDA) added two more – this time the injectables propofol and dexmedetomidine – to its list of drug shortages. The propofol shortage was also previously listed by the American Society for Health-System Pharmacists (ASHP) earlier this month, with manufacturers noting increased demand. Michael Ganio, senior director of pharmacy practice and quali...

The US Food and Drug Administration (FDA) on Monday issued two new product-specific guidance documents for the unproven but highly demanded potential COVID-19 drugs chloroquine phosphate and hydroxychloroquine sulfate. The two generic drugs, approved by FDA as malaria drugs, have been touted by President Donald Trump in press conferences during the pandemic, but clinical trial data regarding their efficacy for COVID-19 remain thin. Regardless, 30 million doses of hyd...

In response to “many emails from stakeholders,” the US Food and Drug Administration (FDA) late Monday clarified a few policies related to drug compounding, including one on the limit on the interstate distribution of compounded drug products for pharmacy compounders. Overall, FDA said its policies are meant to protect patients from unsafe, ineffective and poor-quality compounded drugs while preserving access for patients. In one of the updates, FDA clarifies that a ...

The EU Executive Steering Group on Shortages of Medicines Caused by Major Events is currently establishing, with the pharmaceutical industry, the i-SPOC (industry single point of contact) system to speed up interactions on drug shortages between industry and the steering group, the European Medicines Agency (EMA) said Monday. Although medicine shortages are dealt with at the national level in the EU by national competent authorities, under this new system each pharmaceu...