FDA Policy/General
Former FDA director of orphan product development Timothy Cote is petitioning the agency to “immediately and completely freeze all administrative actions on any regulatory requests from pharmaceutical and medical device companies headquartered in Russia or with majority Russian ownership.” His 2/22 emergency petition cites the Russian invasion of Ukraine
Drugs
FDA has released the FDA-483 issued following a 9/15-9/23/21 inspection at OSRX, Inc., a Missoula, MT, producer of sterile drug products. The form contains one observation that the current laminar airflow studies (smoke studies) of the ISO5 laminar airflow workstation were not performed under conditions
Drugs
FDA has published a guidance, Patient-Focused Drug Development: Methods to Identify What is Important to Patients, describing approaches to identifying what is most important to patients concerning their experience as it relates to the burden of disease/condition and burden of treatment. The document is the second in a
Drugs
Attorney and data scientist Bradley Thompson (Epstein Becker Green) says that although four years ago then-FDA commissioner Scott Gottlieb promised that the agency would release the identifier number (known as the NCT number) assigned by the National Institutes of Health to clinical trials listed online at clinicaltrials.gov, it
Drugs
IQVIA says it appreciates the FDA effort to provide guidance on the use of registry data to support regulatory decision-making for drug and biological products and the agency’s conceptual approach to defining multiple key terms. The firm’s 2/25 letter commented on an FDA draft guidance, Real-
Drugs
FDA has issued three final guidances on cancer clinical trials that agency officials say parallel the goals of President Biden’s effort to renew his 2016 Cancer Moonshot to facilitate continued advancement in cancer prevention, detection, research, and patient care. FDA Oncology Center of Excellence director Richard Pazdur says that
Drugs
FDA has issued Gilead Sciences a complete response letter on its NDA for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor for treating HIV-1 infection in heavily treatment-experienced people with multi-drug resistant HIV-1 infection. The agency cited chemistry, manufacturing and controls issues relating to the
Drugs
Lexicon Pharmaceuticals has voluntarily withdrawn its NDA for sotagliflozin, indicated for reducing the risk of cardiovascular death, hospitalization for heart failure, and urgent visits for heart failure in adult patients with Type 2 diabetes with either worsening heart failure or additional risk factors for heart failure irrespective of left ventricular
Drugs
As FDA begins to transition out of the Covid-19 pandemic, CDER Office of Prescription Drug Promotion (OPDP) staff are likely to resume attending in-person medical conferences and trade shows and will presumably have a renewed interest in reviewing materials disseminated and assessing interactions at the booths in these
Drugs
Clinical trial sites that routinely identify issues of potential non-compliance with good clinical practice (GCP) should review corrective actions (e.g., changes to SOPs or training) to make sure they have fully addressed the non-compliance, ORA Office of Bioresearch Monitoring Operations director Chrissy Cochran told a 2/16
Drugs
FDA has revised an AstraZeneca emergency use authorization (EUA) for Evusheld (tixagevimab co-packaged with cilgavimab) to change the initial dose for the authorized use as Covid-19 pre-exposure prevention in certain adults and pediatric patients. “Based on the most recent information and data available, Evusheld may be less
Drugs
FDA has approved a Sage Chemical ANDA for the first generic version of Mylan’s Apokyn (apomorphine hydrochloride injection) drug cartridges to treat hypomobility “off” episodes (end-of-dose wearing off and unpredictable “on/off” episodes) associated with advanced Parkinson’s disease. FDA notes that the approval is for Sage’
Drugs
FDA has extended by three months its review of a Rhythm Pharmaceuticals supplemental NDA for Imcivree (setmelanotide) for treating obesity and control of hunger in adult and pediatric patients six years of age and older with Bardet-Biedl Syndrome (BBS) or Alström syndrome. The new user fee review action date
Drugs
FDA has tightened its emergency use authorization for GlaxoSmithKline/Vir Biotech’s sotrovimab to restrict its use in some cases. The monoclonal antibody is a treatment for mild-to-moderate Covid-19 in adults and children age 12 and older with positive results of direct SARS-CoV-2 viral testing
Drugs
FDA has granted Boehringer Ingelheim Pharmaceuticals a breakthrough therapy designation for its investigational therapy BI 1015550 and its use in treating idiopathic pulmonary fibrosis. The company says the oral phosphodiesterase 4B inhibitor has the potential to address both pulmonary fibrosis, which is the scarring of lung tissue, and inflammation associated
Drugs
Apricus Biosciences says FDA requests for a new formulation and two new Phase 3 efficacy trials for its Vitaros (alprostadil, DDAIP.HCl) topical cream to treat erectile dysfunction exceed the company’s existing resources and ability to raise capital. In a statement on its Vitaros end-of-review meeting with
Drugs
FDA has released the FDA-483 issued following a 9/23-10/7/21 inspection at Denver Solutions, an Englewood, CO, outsourcing facility. The seven inspection observations were: * failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of
Drugs
FDA has approved a broader indication for Boehringer Ingelheim’s Jardiance (empagliflozin) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults. An agency notice says the drug received priority review for this new indication. Jardiance was originally approved by the agency in 2014 as a
Drugs
FDA has extended its review of a United Therapeutics NDA resubmission for Tyvaso DPI (inhaled treprostinil), indicated for treating pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease, after receiving an information request letter from the agency. According to the company, FDA requested additional information on the pulmonary
Drugs
The CDER Office of Pharmaceutical Quality (OPQ) 2021 annual report says that in response to a White House call for strategies to improve medicine supply chain transparency and incentivize resilience, it is working on an emerging technology program, a framework for regulatory advanced manufacturing evaluation, and quality management maturity ratings.
Drugs
FDA has again issued Mallinckrodt a Complete Response Letter on its NDA for terlipressin to treat adults with hepatorenal syndrome (HRS), an acute and life-threatening condition involving rapid reduction in kidney function. “Within the last two weeks, it became necessary to identify a new packaging and labeling manufacturing facility
Drugs
FDA has released a 28-page FDA-483 with 13 observations from a 9/20-11/30/21 inspection at Edge Pharma, a Colchester, VT, outsourcing facility. The inspection observations were: * buildings used in the manufacturing, processing, packing, and holding of a drug product are not maintained in a good