FDA Policy/General
Federal Register notice: FDA has ordered the permanent debarment of Michael L. Babich from providing services in any capacity to a person that has an approved or pending drug product application. The order is based on Babich’s recent conviction related to alleged illegal actions in his previous capacity as
Drugs
In a complete response letter, FDA has informed Liquidia Technologies that it cannot approve the company’s NDA for its LIQ861 (treprostinil) inhalation powder to treat pulmonary arterial hypertension. The company says FDA indicated a need for additional information and clarification on chemistry, manufacturing, and controls data on the drug
FDA Policy/General
Federal Register notice: HHS is announcing its intent to withdraw FDA’s Marketed Unapproved Drugs – Compliance Policy Guide, Sec. 440.100, Marketed New Drugs Without Approved NDAs or ANDAs, and to request information from the public regarding drugs that may be grandfathered or generally recognized as safe and effective. To
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Product Jurisdiction and Combination Products — 21 CFR Part 3” (OMB Control Number 0910-0523). The revision is mandated by the Cures Act and pertains to FDA’s Office of Combination Products’ (OCP) designated combination product-specific submission
FDA Policy/General
Federal Register notice: FDA has sent to OMB an information collection extension entitled “Obtaining Information to Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities” (OMB Control Number 0910-0883). This is an extension of research that began last year. FDA says it has learned about barriers and opportunities encountered
Drugs
Pharmaceutical Research and Manufacturers of America, the Partnership for Safe Medicines, and the Council for Affordable Health Coverage have filed suit in DC federal court to block HHS and FDA from implementing a program to permit the importation of some drugs from Canada. The suit asks the court to hold
Drugs
A 1/13-2/12 FDA inspection at two AuroLife Pharma drug manufacturing facilities in Dayton, NJ, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 10/16 Warning Letter says specific violations were: * failing to thoroughly investigate any unexplained discrepancy or failure of a
Drugs
FDA has released a final guidance on Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff. The document’s development was mandated in the 21st Century Cures Act under Section 507, Qualification of Drug Development Tools (DDTs). Once finalized, FDA says the document will represent the agency’
Drugs
FDA has approved an Alnylam Pharmaceuticals NDA for Oxlumo (lumasiran) as the first treatment for primary hyperoxaluria Type 1 (PH1), a rare genetic disorder. Primary hyperoxalurias (PHs) are caused by excess production of oxalate, a substance consumed in food and also produced by the body, an FDA release says. “PH1
Drugs
FDA has published a guidance, Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA, describing an enhanced pathway for discussions between the agency and applicants for ANDAs for a complex product, as defined in the guidance. The document specifically provides information on requesting and conducting product development
Devices
During an 11/12 online listening session for the CDRH Digital Health Center of Excellence (DHCoE), a panel of industry experts discussed whether FDA has developed the correct goals for the DHCoE and how best to collaborate on the Center’s work. DHCoE director Bakul Patel said FDA considers digital
Drugs
FDA says the expiration date for 42 lots of Octapharma Produktionsges’ Cutaquig immune globulin, subcutaneous (human)-hipp 16.5% solution can be extended from 24 to 36 months when stored at a cooler temperature under conditions specified in the agency notice. FDA says the 42 lots covered by the new
Devices
FDA has cleared a Neuronetics 510(k) for its TouchStar treatment, a three-minute intermittent theta burst protocol for use with its NeuroStar Advanced Therapy System. “The new protocol arms physicians with the ability to now offer a third FDA-cleared treatment protocol with NeuroStar Advanced Therapy, a non-drug,
Devices
FDA has recognized the ANSI National Accreditation Board (ANAB) as an accreditation body for the Accreditation Scheme for Community Assessment (ASCA) pilot. ANSI (the American National Standards Institute) says the agency recognition allows ANAB to accredit testing laboratories to perform premarket testing for medical device companies. The ASCA pilot relies
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: AuroLife Pharma, Dayton, NJ (10/16): FDA inspected the firm 1/13-2/12 and found significant GMP violations for finished pharmaceuticals.
FDA Policy/General
Three Covington & Burling attorneys say in an online post the incoming administration of President-elect Joe Biden is likely to have these priorities at FDA: * science-based decision-making to highlight career scientific staff and rebuild what is seen as an erosion of public trust in federal health agencies;
FDA Policy/General
FDA Office of Trade, Mutual Recognition, and International Arrangements senior advisors Anne Kirchner and Joseph Rieras say the United States-Mexico-Canada Agreement (USMCA) that took effect 7/1 “aligns regulatory standards with agency practices, betters the quality of products available to American consumers, and levels the playing field for
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Clinical Drug Interaction Studies With Combined Oral Contraceptives. The document is intended to assist sponsors in evaluating the need for and design drug-drug interaction (DDI) studies involving combined oral contraceptives during drug development as well as determining how
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Elemental Impurities in Animal Drug Products — Questions and Answers.” The document provides recommendations to sponsors on the control of elemental impurities in animal drug products, including all dosage forms and routes of administration. To view the notice, click here.
Drugs
HHS is sidestepping FDA to terminate the agency’s unapproved drug initiative (UDI) as part of the Trump administration’s efforts to reduce prescription drug costs. UDI is an FDA program launched through guidance documents issued in 2006 and 2011. The program aimed to legalize marketed drugs that lack FDA
Drugs
AstraZeneca says it is preparing an emergency use authorization request for its investigational vaccine AZD1222 after an interim analysis showed that the vaccine was highly effective in preventing Covid-19 and no hospitalizations or severe disease cases were reported in participants receiving the vaccine. There were a total of 131
Drugs
FDA has launched its Orphan Drug Designation Portal to support therapy development for rare diseases by enhancing sponsor communication with the agency and to simplify orphan drug designation submissions. “This important initiative is part of broader technology modernization efforts at the FDA to develop a more connected information technology system,