FDA Policy/General
President Donald Trump 11/1 nominated MD Anderson chief medical officer Stephen Hahn to be FDA commissioner. Current acting commissioner Ned Sharpless is unexpectedly heading back to his previous position as National Cancer Institute dirctor. While Hahn navigates the Senate confirmation process, HHS assistant secretary for health Brett Giroir will
FDA Policy/General
Federal Register notice: FDA has announced a 12/10 Cardiovascular and Renal Drugs Advisory Committee meeting. Panel members are scheduled to discuss a Correvio International NDA for vernakalant HCl solution for the proposed indication of rapid conversion of recent onset atrial fibrillation to sinus rhythm for non-surgery patients. To
FDA Policy/General
Federal Register notice: FDA has determined that Boehringer Ingelheim’s Mexitil (mexiletine hydrochloride) capsules, 150 mg, 200mg, and 250 mg, were not withdrawn from sale for safety or effectiveness reasons. The determination will allow FDA to approve ANDAs that reference Mexitil if all other legal and regulatory requirements are met.
FDA Policy/General
Federal Register notice: FDA has announced an 11/21 public meeting entitled “Office of Minority Health and Health Equity Public Meeting on Strategies to Improve Health Equity Amidst the Opioid Crisis.” The meeting is intended to share information and obtain public perspectives on the crisis and how it specifically affects
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance on “Providing Regulatory Submissions in Electronic Format: IND Safety Reports.” The document describes the electronic format sponsors will be required to use when they electronically submit IND safety reports to CDER or CBER for serious and unexpected suspected adverse reactions
FDA Policy/General
Federal Register notice: FDA has announced a 12/3-4 Science Advisory Board to the National Center for Toxicological Research (NCTR)advisory committee meeting. On 12/3, the NCTR director will provide a Center-wide update on scientific initiatives and accomplishments during the past year. An overview of a subcommittee
FDA Policy/General
Federal Register notice: FDA has classified continuous glucose monitor data management systems into Class 1 (general controls). The classification decision is based on a 2014 Dexcom, Inc.-submitted request for De Novo classification of its Studio on the Cloud Data Management Software. FDA has identified the system as an electronic
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance for industry entitled “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software.” The document explains when a Type V DMF may be used to submit information regarding a combination product for which CDER
FDA Policy/General
Federal Register notice: FDA has classified self-fitting air-conduction hearing aids into Class 2 (special controls). The classification was made based on a 5/2019 Bose Corp.-submitted De Novo classification request for the Bose Hearing Aid. FDA has identified such aids as a wearable sound amplifying device that
FDA Policy/General
Federal Register notice: FDA is proposing to withdraw approval of a Watson Laboratories ANDA for oxycodone hydrochloride and ibuprofen tablets and is announcing an opportunity for the holder of the ANDA to request a hearing on this action. The basis for the proposal is that the company has repeatedly failed
FDA Policy/General
Federal Register notice: FDA is proposing to withdraw approval of an InvaGen Pharmaceuticals ANDA for trandolapril tablets and is announcing an opportunity for the holder of the ANDA to request a hearing on this action. The basis for the proposal is that the company has repeatedly failed to submit required
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: PetNet Solutions, Knoxville, TN (10/17): FDA inspected the firm’s Woburn, MA drug manufacturing facility and cited significant GMP violations for
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Categorization — 42 CFR 493.17” (OMB Control Number 0910-0607). The collection is described in a guidance under the same title, which discusses procedures FDA uses to
FDA Policy/General
Federal Register notice: FDA has posted a list of FDA information collections recently approved by OMB. They are: * Physician Interpretation of Information About Prescription Drugs in Scientific Publications Versus Promotional Pieces * Guidance on Meetings with Industry and Investigators on the Research and Development of Tobacco Products * Reporting Harmful and Potentially
FDA Policy/General
Federal Register notice: FDA has announced an 11/21 public meeting seeking input on a report to Congress about pediatric study requirements. Some of the issues to be discussed include: * Hearing from stakeholders about the public health impact that pediatric legislation may have had on them or their communities; * Understanding
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Planning for the Effects of High Absenteeism To Ensure Availability of Medically Necessary Drug Products” (OMB Control Number 0910-0675). The collection supports guidance recommendations intended to encourage manufacturers of drug and therapeutic biological products, and any
FDA Policy/General
Orthopedic Surgical Instruments Put Into Class 2 Federal Register notice: FDA classifies orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation into Class 2 (special controls). 10/25/2019 Draft Guide on Homeopathic Drug Products Federal Register notice: FDA makes available a revised draft guidance entitled “Drug Products
FDA Policy/General
Patricia Industries has acquired Toronto, Canada-based medical device company Laborie from Audax Private Equity. Laborie develops technology for the diagnosis and treatment of urologic and gastrointestinal disorders. Its sales were $117 million in fiscal year 2018. Pfizer has agreed to buy San Francisco biotech Medivation for about $14 billion.
FDA Policy/General
Federal Register notice: FDA has classified orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation into Class 2 (special controls). This action was in response to a 1/2018 request from Cartiva Inc. for accessory classification of its reusable implantation instruments for the Cartiva Synthetic Cartilage Implant. Such
FDA Policy/General
Federal Register notice: FDA has made available a revised draft guidance entitled “Drug Products Labeled as Homeopathic.” The document describes how FDA intends to prioritize enforcement and regulatory action on homeopathic products marketed without approval that potentially pose a risk to public health. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is withdrawing the NDA approval of Allergan Pharmaceuticals’ Lo Minastrin FE (ethinyl estradiol tablets, 0.01 mg; ethinyl estradiol and norethindrone acetate tablets, 0.01 mg/1mg; and ferrous fumarate tablets, 75 mg). Allergan notified the agency that the drug product was no longer marketed and
FDA Policy/General
Federal Register notice: FDA has classified internal therapeutic massagers into Class 2 (special controls). This action is based on an 8/20 National Center for Pelvic Pain Research Devices request for De Novo classification of the AHIP Internal Trigger Point Wand. Such devices are identified as hand-held prescription devices