Public Policy Updates

12/13/21 — Efficient Laboratories is voluntarily recalling Rompe Pecho products due to microbial contamination concerns. These products are used to treat symptoms of the flu and the common cold, and each are packaged in a box containing a bottle of the liquid product.  Read the FDA recall announcement, which includes a list of recalled products.

12/9/21 — The FDA amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 16 and 17 years of age at least six months after completion of primary vaccination with the Pfizer-BioNTech COVID-19 Vaccine. The CDC followed up on FDA’s action by likewise … Continued

Edge Pharma, LLC is voluntarily recalling all lots of all drugs due to process issues that could lead to a lack of sterility assurance for products intended to be sterile and could impact the safety and quality of non-sterile products. Read the FDA recall notice.

12/7/21 — As the SARS-CoV-2 virus continues to mutate over time, genetic variations could impact the performance of some COVID-19 molecular, antigen, and serology tests. The FDA website “SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests” provides information regarding the impact of viral mutations on COVID-19 tests, recommendations for clinical laboratory staff and healthcare providers, and information … Continued

12/6/21 — Federal Courts have suspended implementation of the OSHA COVID-19 Vaccination and Testing Emergency Temporary Standard and the CMS Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule until the courts can review and rule on challenges to the mandates. Both agencies remain confident of their authority to implement necessary measures to protect the health … Continued

12/3/21 — The FDA revised the emergency use authorization (EUA) of bamlanivimab and etesevimab (previously authorized for pediatric patients 12 years of age and older weighing at least 40 kilograms, or about 88 pounds), to additionally authorize bamlanivimab and etesivimab administered together for the treatment of mild to moderate COVID-19 in all younger pediatric patients, including newborns, who … Continued

11/23/21 — The FDA authorized three over-the-counter (OTC) COVID-19 antigen diagnostic tests for people age 14 years or older with a self-collected nasal swab sample or people age 2 years or older when an adult collects the nasal swab sample. These tests are: InBios SCoV-2 Ag Detect Rapid Self-Test delivers results in about 20 minutes. The … Continued