FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Clinical Laboratory Improvement Amendments (CLIA) of 1988 Waiver Applications.” CLIA requires that clinical laboratories obtain a certificate from HHS before accepting materials derived from the human body for laboratory tests. Laboratories that perform only tests that are
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Standards Development and the Use of Standards in Regulatory Submissions Reviewed.” The document provides CBER recommendations on the use of standards in product development and control as well as the use of such standards in CBER’s managed review
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Mariposa Labs Boise, ID (3/14): FDA inspected the firm 3/2018 and cited significant GMP violations for finished pharmaceuticals. The firm was also cited for manufacturing unidentified, unapproved
FDA Policy/General
Federal Register notice: FDA has announced a 5/8 Pulmonary-Allergy Drugs Advisory Committee meeting. Panel members are scheduled to discuss a Chiesi USA NDA for mannitol inhalation powder, indicated for managing cystic fibrosis to improve pulmonary function in patients 18 years of age and older in conjunction with standard
FDA Policy/General
Federal Register notice: FDA has announced a 4/25 Antimicrobial Drugs Advisory Committee meeting. Panel members are scheduled to discuss one or more possible pathways for approval of rabies virus monoclonal antibodies for use as the passive-immunization component of post-exposure prophylaxis. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance “Rare Diseases: Natural History Studies for Drug Development.” The document says that a natural history study collects information about a disease’s natural history in the absence of an intervention, from the disease’s onset until either its resolution or
FDA Policy/General
Workshop on Nontuberculous Mycobacterial Disease Drugs Federal Register notice: FDA announces a 4/8 public workshop entitled “Development of Antibacterial Drugs for the Treatment of Nontuberculous Mycobacterial Disease.” 03/22/2019 Antimicrobial Drugs Advisory Committee Meeting on Bacitracin Federal Register notice: FDA announces a 4/26 Antimicrobial Drugs Advisory Committee
FDA Policy/General
Federal Register notice: FDA has announced a 4/26 Antimicrobial Drugs Advisory Committee meeting. Panel members are scheduled to discuss the safety and effectiveness of bacitracin for intramuscular injection for treating infants with pneumonia and empyema caused by staphylococci shown to be susceptible to the drug, which is the only
FDA Policy/General
Federal Register notice: FDA has announced a 4/8 public workshop entitled “Development of Antibacterial Drugs for the Treatment of Nontuberculous Mycobacterial Disease.” FDA officials and attendees are expected to discuss clinical trial design considerations, including endpoints, related to developing antibacterial drug products for treating the disease. To view the
FDA Policy/General
Oregon attorney general Ellen Rosenblum says Pfizer will pay $975,000 to settle state charges that it distributed misleading marketing materials and coupons to Oregon consumers. Rosenblum says the coupons were designed to help consumers afford copays or deductibles associated with branded drugs. Some $620,000 of the settlement money
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Pediatric HIV Infection: Drug Product Development for Treatment.” The document provides general recommendations for developing antiretroviral drug products for treating human immunodeficiency virus infection in pediatric patients. It also addresses when to initiate pediatric formulation development and begin pediatric
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis.” The document provides sponsors with nonclinical and clinical recommendations specific to developing systemic drug products, with a focus on long-acting systemic drug products (including small
FDA Policy/General
FDA commissioner Scott Gottlieb’s departure next month leaves a full plate of new initiatives and policy directives he spearheaded in the almost two years he was at helm, and it is natural to wonder which will fall through the cracks once he leaves. One prediction has the agency staying
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Medical Devices: Use of Symbols in Labeling — Glossary to Support the Use of Symbols in Labeling” (OMB Control Number 0910-0740). The collection follows a 2016 final rule that allows the optional use in medical device labeling
FDA Policy/General
FDA’s medical product programs appear to benefit most from the Trump Administration’s proposed 7% boost ($419 million) to the agency’s 2020 budget (see earlier story). According to a just-released budget justification document for FDA, the budget request for medical product safety- and availability-related programs totals
FDA Policy/General
Clinical Trial Enrichment Strategies Guide Federal Register notice: FDA makes available a final guidance entitled “Enrichment Strategies for Clinical Trials to Support Demonstration of Effectiveness of Human Drugs and Biological Products.” 03/15/2019 Guide on Hematologic Disorders Drug Development Federal Register notice: FDA makes available a final guidance entitled
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Enrichment Strategies for Clinical Trials to Support Demonstration of Effectiveness of Human Drugs and Biological Products.” The document provides several types of enrichment strategies and examples of potential clinical trial designs. It also discusses potential regulatory considerations when using
FDA Policy/General
Federal Register notice: FDA made available a final guidance entitled “Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals.” The document outlines nonclinical studies recommended for developing pharmaceuticals used to treat patients with such disorders and addresses comments received to the docket. It is intended to streamline product
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers.” The document provides information to sponsors on risk-based approaches to monitoring of investigational studies of human drug and biological products, medical devices, and product combinations. It
FDA Policy/General
Federal Register notice: FDA has made available a final guidance on “Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices).” The document updates agency policy on using animal-derived material in medical device manufacturing. It says that animal-derived materials may carry a risk of
FDA Policy/General
[Commentary by Jim Dickinson] Aviation experts have been quick to point out a cause of Boeing’s current crisis that’s been in plain sight ever since Ronald Reagan deregulated the industry and spread that success through the rest of the government – including FDA. In a word: Coziness. Regulated industries
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002” (OMB Control Number 0910-0510). To view the notice, click here.