FDA Policy/General
Federal Register notice: FDA has announced a 7/12 public meeting entitled “Limited Population Pathway for Antibacterial and Antifungal Drugs.” The meeting is intended to provide a public forum for FDA to listen to comments on a 6/2018 draft guidance on the limited population pathway. The agency is also
FDA Policy/General
FDA has announced a 5/31 public hearing for it to receive input on the agency’s regulatory strategy and pathways for products containing cannabis or cannabis-derived compounds to be marketed. The agency is interested in hearing whether there are particular safety concerns that it needs to consider in
FDA Policy/General
FDA commissioner Scott Gottlieb and deputy commissioner for policy, legislation, and international affairs Anna Abram say the agency is implementing risk-based regulation of the safety and effectiveness of heritable intentional genomic alterations in animals. Writing in an FDA Voices blog post, the two say the innovations comprise changes made
FDA Policy/General
An FDA discussion paper is seeking comments on a proposed framework for modifications to artificial intelligence- and machine learning-based software as a medical device that is based on the internationally harmonized International Medical Device Regulators Forum risk categorization principles, FDA’s benefit/risk framework, management principles in the agency’
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Dong Yuan Technology Co. Shandong Province, China (3/18): FDA inspected the firm 9/2018 and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to
FDA Policy/General
Federal Register notice: FDA is proposing to amend the biologics regulations by removing the specified test for the presence of mycoplasma for live virus vaccines and inactivated virus vaccines produced from in vitro living cell cultures. The agency says the existing test for mycoplasma is restrictive in that it identifies
FDA Policy/General
Federal Register notice: FDA has issued a final rule amending general biologics regulations relating to time of inspection requirements and to remove duties of inspector requirements. FDA is taking the action to remove outdated requirements and accommodate new approaches, such as a risk-based inspection frequency for drug and device
FDA Policy/General
Federal Register notice: FDA has issued a final rule to classify in vitro diagnostic devices for Bacillus species detection into Class 2 (special controls) and to continue to require a premarket notification (510(k)) to provide a reasonable assurance of device safety and effectiveness. An in vitro diagnostic device for
FDA Policy/General
Federal Register notice: FDA has issued a final rule to classify posterior cervical screw systems into Class 2 (special controls) and to continue to require a premarket notification (510(k)) to provide a reasonable assurance of device safety and effectiveness. The agency identifies a posterior cervical screw system as a
FDA Policy/General
Federal Register notice: FDA is amending the medical device reports of corrections and removals regulation to correct three inaccurate cross-references. This action is editorial in nature and is intended to improve the accuracy of the agency’s regulations. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is proposing to amend and repeal parts of its radiological health regulations covering recommendations for radiation protection during medical procedures, certain records and reporting for electronic products, and performance standards for diagnostic x-ray systems and their major components, laser products, and ultrasonic therapy products. The
FDA Policy/General
DEVICES FDA has cleared a Deerfield Imaging 510(k) to market its SYMBIS stereotactic brain biopsy system in the U.S. The device allows for a biopsy to be performed while a patient is inside an MRI scanner that is intended to improve targeting and procedure times. EDAP TMS has
FDA Policy/General
Pfizer Inc. and Allergan say they are not going forward with their $160 billion merger, in part because of new U.S. Treasury rules aimed at thwarting tax inversions. Pfizer has agreed to pay Allergan $150 million for reimbursement of expenses associated with the transaction. The National Institutes of Health
FDA Policy/General
Just as he leaves the agency, FDA commissioner Scott Gottlieb has received the go-ahead for his proposed reorganization of the Office of the Commissioner and several changes to other agency elements. The Regulatory Affairs Professionals Society (RAPS) says Gottlieb told staff the reorganization plan “elevates the role of the
FDA Policy/General
Federal Register notice: FDA has awarded Vertex Pharmaceutical a priority review voucher after it determined that a qualified rare pediatric disease product gained approval. The agency recently approved the company’s Symdeko (tezacaftor/ivacaftor), indicated for treating patients with cystic fibrosis aged 12 years and older who are homozygous for
FDA Policy/General
Federal Register proposed rule: FDA has proposed to update the mammography regulations that were issued under the Mammography Quality Standards Act of 1992 and the Federal Food, Drug, and Cosmetic Act to modernize the regulations by incorporating current science and mammography best practices. The updates are intended to improve the
FDA Policy/General
Federal Register notice: FDA has announced the renewal of the Cellular, Tissue and Gene Therapies Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 10/28/2020. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Pediatric Information Incorporated Into Human Prescription Drug and Biological Product Labeling.” The document is intended to assist applicants in determining the appropriate placement and content of pediatric information in human prescription drug and biological product labeling as described in
FDA Policy/General
Federal Register notice: FDA has announced a 4/29 regional public meeting entitled “U.S. Food and Drug Administration and Health Canada Joint Regional Consultation on the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).” The purpose of the public meeting is to provide information
FDA Policy/General
Federal Register notice: FDA has announced a 5/2 annual meeting of the Reagan-Udall Foundation that will discuss its activities and how they support FDA. Center officials will also hold a panel discussion on pressing FDA initiatives suitable for public-private partnerships. To view the notice, click here.
FDA Policy/General
FDA, along with many other federal agencies, is watching how the Supreme Court handles a case testing the long-standing notion that courts should defer to federal agencies in the agencies’ interpretation of their own regulations. Although the case before the high court involves veterans’ benefits, observers say the decision
FDA Policy/General
FDA says the iMedDo Web site takes orders for NeuSilver Colloidal Silver and NeuKids lower dose silver for pets and children. A just-released 2/19 Warning Letter gives examples of Web site claims that provide evidence that the products are intended for use as drugs. Since the products are