Newly authorized test detects genetic cancer mutations in 468 unique genes
Category Archives: Drug Safety Information Podcasts
FDA approves treatment for rare genetic enzyme disorder
FDA approves treatment for rare genetic enzyme disorder
FDA grants marketing authorization of the first device for use in helping to reduce the symptoms of opioid withdrawal
FDA permits marketing of the first device for use in helping to reduce the symptoms of opioid withdrawal
Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA advisory about deadly risks associated with kratom
A botanical substance known as kratom has raised significant concerns given its increasing prevalence and potential safety risks. The FDA has issued a public health advisory related to mounting concerns regarding risks associated with the use of kratom.
FDA approves pill with sensor that digitally tracks if patients have ingested their medication
The U.S. Food and Drug Administration today approved the first drug in the U.S. with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken. The product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults.
Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to improve FDA review of shared Risk Evaluation and Mitigation Strategies to improve generic drug access
To further streamline the submission and review process for shared system REMS (for any REMS that includes more than one medication), today the FDA is releasing a draft guidance for industry, Use of a Drug Master File for Shared System REMS Submissions, that describes how applicants can submit collective sets of files to the FDA that represent all participating firms.
Statement from FDA Commissioner Scott Gottlieb, M.D., on a practical approach to ensuring timely implementation of FDA’s menu labeling rule
FDA menu labeling guidance
FDA clears common blood cell count test that offers faster results for patients and providers
The U.S. Food and Drug Administration today cleared a complete blood cell count (CBC) test that, based on its categorization, can be run in more health care settings, including physicians’ offices, clinics or other types of health care facilities, by a wider range of personnel (e.g. support staff). This broadened test access will allow for faster availability of results.
FDA approves first treatment for certain patients with Erdheim-Chester Disease, a rare blood cancer
FDA expands approval of Zelboraf (vemurafenib) to include treatment of certain adult patients with Erdheim-Chester Disease, a rare blood cancer. This is the first FDA-approved treatment for ECD.
Statement from FDA Commissioner Scott Gottlieb, M.D., on implementation of agency’s streamlined development and review pathway for consumer tests that evaluate genetic health risks
Statement from FDA Commissioner Scott Gottlieb, M.D., on implementation of agency’s streamlined development and review pathway for consumer tests that evaluate genetic health risks