Puerto Rico

Increasing the capacity for local development and production of medicines and other health technologies in Latin America and the Caribbean is among the objectives of the new deal.

Of GMP warnings for OTC hand sanitizers, 114 have been submitted by FDA since pandemic began, with first sent in late April 2020, and another 12 for false COVID-19 claims, with first sent on 1 April. One GMP warning for hand sanitizer product is listed in both 2018 and 2019.

In the wake of signing a drug transfer and development agreement with Biosimilar Solutions in the firms’ native Puerto Rico, OcyonBio’s CEO Robert Salcedo spoke with Generics Bulletin about the company’s ambitions to put the US territory on the map for biosimilars.

Tuberculosis or cancer, sterility assurance or shortages, the choices come at you fast; Takeda, Wintac, Banco Vida updates.

Until FDA on 23 June posted report about Golden Nutrition Inc.’s herbal supplement, violative COVID-19 claims had been found online and in advertising through other channels. Other consumer health recalls in US include more than 2.5m bottles of Gaviscon Liquid Antacid missing a safety warning on labels.

UK pharma announced that in 2021 it will close its manufacturing facility in Carlisle, PA, where around 260 people are employed making the Emergen-C line. It will move the manufacturing to its Guayama, PR, facility.

The need to screen individuals in dengue-endemic areas for prior infection before administering Sanofi’s vaccine will be difficult to operationalize, particularly in the absence of a reliable and rapid diagnostic, experts say; Advisory Committee on Immunization Practices working group aims for full committee vote on use recommendations in February 2020.

FDA recently sampled and tested targeted supplement products in a follow-up inspection to a Life Rising recall linked to lead contamination in 2017. Latest updates to FDA recalls database includes nearly 5.8m pounds of antibacterial or antiseptic hand washes that Inopak Ltd. produced in a facility found to be outside good manufacturing practices regulations.

Pfizer Consumer Healthcare division recalls one lot of ThermaCare Back Pain Therapy HeatWraps, up to 16HR pain relief, because the products could include cells that have a higher cell temperature than specified. Firm in late 2018 recalled six lots of ThermaCare HeatWraps Muscle Joint Therapy 8-hour strength due to reports of leaking heat cells.

The September hurricane destroyed Puerto Rican medical device plants, causing a shortage of several key products that's still being felt. FDA Commissioner Scott Gottlieb said Monday that the agency is allowing more imports and considering other tactics to ease the shortage.