FDA Policy/General
Federal Register notice: FDA has announced a 6/26 joint Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee meeting. Panel members are scheduled to review a Pain Therapeutics NDA for an NDA for oxycodone extended-release capsules, indicated for managing pain severe enough
FDA Policy/General
FDA has published a guidance on “Enforcement Policy — OTC Sunscreen Drug Products Marketed Without an Approved Application” that describes the agency’s enforcement approach with respect to such during the period before a final sunscreen monograph becomes effective. The document notes that OTC sunscreens marketed without approved applications and containing
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for its “Guidance for Industry: Controlled Correspondence Related to Generic Drug Development” (OMB Control Number 0910-0797). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has established a public docket to assist with developing a policy or guidance document on assessing pH-dependent drug-drug interactions (DDIs). The agency notes that recent draft guidance documents only focus on enzyme- and transporter-based DDIs and do not include a framework for assessing
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Bioanalytical Method Validation.” The document incorporates public comments to a revised 2013 draft as well as the latest scientific feedback concerning bioanalytical method validation. It is intended to provide the most up-to-date information needed by drug developers to
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Acne Vulgaris: Establishing Effectiveness of Drugs Intended for Treatment.” The document provides recommendations to industry for establishing the clinical effectiveness of such drugs. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has published a list of PMAs that have recently been approved. The list provides the public with the availability of the associated PMA safety and effectiveness summaries. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft revised guidance for industry entitled “Documenting Electronic Data Files and Statistical Analysis Programs.” The document is intended to inform sponsors about recommendations for documenting electronic data files and statistical analyses submitted to the Center for Veterinary Medicine to support new animal
FDA Policy/General
Federal Register notice: FDA has published a draft guidance on “Cytomegalovirus in Transplantation: Developing Drugs to Treat or Prevent Disease.” The document provides recommendations for developing such drugs for treating patients who have undergone solid organ or hematopoietic stem cell transplantation. It addresses FDA’s current thinking on the overall
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders.” The document provides recommendations for establishing clinical effectiveness for such drugs intended to treat the condition associated with obesity and other conditions that do not cause
FDA Policy/General
Blood Establishment Software Put Into Class 2 Federal Register final rule: FDA classifies blood establishment computer software and accessories (regulated under product code MMH) into Class 2 (special controls). 05/18/2018 Panel to Review PneumRx PMA for Elevair Endobronchial Coil System Federal Register notice: FDA announces a 6/14
FDA Policy/General
While the Trump Administration has its sights on slashing program areas at various federal agencies, FDA continues to get strong support on Capitol Hill for increased funding for new and existing program areas. On 5/16, a House Appropriations Committee mark-up for FDA’s fiscal year 2019 funding increased
FDA Policy/General
Federal Register final rule: FDA has classified blood establishment computer software and accessories (regulated under product code MMH) into Class 2 (special controls). The agency also provided notice that it does not intend to exempt BECS and BECS accessories from premarket notification requirements. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 6/14 Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee meeting to review a PneumRx PMA for the PneumRx Elevair Endobronchial Coil System. The agency described the device as a first of a kind implantable lung reduction coil for
FDA Policy/General
Federal Register notice: FDA has published a list of recent information collections that have been approved by OMB. Approved collections include: * Medical Devices; Humanitarian Use Devices * Medical Devices; Device Tracking * Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine * Certification to Accompany Drug,
FDA Policy/General
Federal Register notice: FDA has announced a 7/18-19 Blood Products Advisory Committee. On the first day of the meeting, panel members will provide advice regarding bacterial risk control strategies to enhance the safety and availability of platelets for transfusion. On the second day, the panel and members from
FDA Policy/General
Federal Register proposed rule: FDA has proposed to amend its regulations concerning the classification of products as biologics, devices, drugs, or combination products, and their assignment to agency components for premarket review and regulation. This proposed rule would update combination product regulations to clarify their scope, streamline and clarify the
Drugs
Three stakeholders are raising questions about proposed FDA research surveying healthcare professionals on prescription drug promotion. Pharmaceutical Research and Manufacturers of America (PhRMA) says the agency has not followed Paperwork Reduction Act (PRA) procedures that require it to provide adequate means to request and obtain a copy of the survey.
FDA Policy/General
Federal Register notice: FDA has announced a 7/9 public meeting on “Patient-Focused Drug Development for Chronic Pain” that is intended to provide patients with an opportunity to present their perspectives on the impacts of chronic pain, views on treatment approaches for chronic pain, and challenges or barriers to
FDA Policy/General
Federal Register notice: FDA has announced a Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee meeting 6/20 to review and discuss a list of molecular targets for which evidence or biologic rationale exist to determine their potential relevance to the growth or progression of one or more pediatric
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Product Quest MFG, Daytona Beach, FL (4/16): FDA inspected the firm 10/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to maintain
FDA Policy/General
Federal Register notice: FDA has made available a draft entitled “Pediatric HIV Infection: Drug Development for Treatment.” The document provides general recommendations on developing such drug products, including when sponsors should initiate pediatric formulation development and begin pediatric studies to evaluate antiretroviral drug products for treating HIV infection. To view