FDA Policy/General
Context Therapeutics, a biopharma company dedicated to developing new medicines for patients with hormone responsive cancers, announced that it has acquired from Arno Therapeutics the worldwide rights to Apristor (onapristone XR). Onapristone has been studied in two Phase 2 metastatic breast cancer clinical trials. In these trials, meaningful clinical benefit
FDA Policy/General
Federal Register notice: FDA has announced the establishment of a docket to solicit public comment on a proposal to publish a summary of FDA’s review of Risk Evaluation and Mitigation Strategy (REMS) assessments. The purpose of the docket is to increase agency transparency and promote exchange of information regarding
FDA Policy/General
Federal Register notice: FDA has announced a 12/11 public workshop entitled “Evaluating the Effect of the Opioid Analgesics Risk Evaluation and Mitigation Strategy Education Program on Prescribing Behaviors and Patient Outcomes — Exploring the Path Forward for Assessment.” Its purpose is to obtain scientific input on methods to evaluate the
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Medical Devices; Device Tracking — 21 CFR Part 821” (OMB Control Number 0910-0442). The federal Food, Drug, and Cosmetic Act gives FDA authority to require a manufacturer to adopt a method for tracking a Class 2 or
FDA Policy/General
In an online story, Politico reports that many senior officials within FDA are expressing alarm about a 10/21 Executive Order issued by President Trump that would make it easier to fire federal employees who have Civil Service protection. “There’s a legitimately palpable fear this could be wielded as
FDA Policy/General
UC Hastings School of Law professor Dorit Reiss says that while FDA was not designed to be independent, it is perhaps time to discuss whether it should be. Writing in a StatNews opinion piece, Reiss cites the concerns of public health experts and lay observers that FDA will prematurely approve
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery,” (OMB Control Number 0910-0697). The collection applies to feedback that is intended to provide insights into customer or stakeholder perceptions, experiences and expectations, provide
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile” (OMB Control Number 0910-0614). FDA says that it may be appropriate for certain medical products that are in the stockpile to be
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Cosmax USA, Ridgefield Park, NJ (10/15): FDA inspected the firm in February and found significant GMP violations for finished pharmaceuticals. For example, Cosmax failed to thoroughly investigate any
FDA Policy/General
AstraZeneca has sold the U.S. rights to its anesthetic portfolio to Aspen Global for $555 million. The portfolio includes Diprivan, EMLA, Xylocaine/Xylocard/Xyloproct, Marcaine, Naropin, Carbocaine and Citanest, according to the companies. The deal comes about 14 months after Aspen acquired the non-U.S. rights to the
FDA Policy/General
DEVICES FDA has cleared a Butterfly Network 510(k) for what the sponsor describes as the world’s first “ultrasound-on-a-chip” based imaging system, the Butterfly iQ for the iPhone. The clearance covers 13 clinical applications, the “broadest ever for a single ultrasound transducer,” the company says. “By
FDA Policy/General
Comment Period Reopened on Metered Dose Inhaler Guide Federal Register notice: FDA reopens the comment period for its “Metered Dose Inhaler and Dry Powder Inhaler Drug Products — Quality Considerations; Draft Guidance for Industry.” 10/30/2020 Comment Period Extended on E-Data Files guide Federal Register notice: FDA extends the
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 11 ANDAs from multiple applicants after they notified the agency that the drug products were no longer marketed and requested that they be withdrawn. To view the notice, click here.
FDA Policy/General
CDER Office of Prescription Drug Promotion (OPDP) director Tom Abrams has retired effective 10/23. Abrams spent 27 years at FDA, 20 of them at the helm of OPDP. Advertising and Promotion Policy Staff head Catherine Gray is serving as acting director. She has over 20 years of experience, including
FDA Policy/General
Federal Register notice: FDA announces an 11/19 virtual public meeting on reauthorizing the Biosimilar User Fee Act (BsUFA) for fiscal years 2023 through 2027. BsUFA authorizes FDA to collect user fees to support the review process for biosimilar biological products. The current legislative authority for BsUFA expires 9/20/
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products. The document provides guidance about the nonclinical information FDA recommends to support development and approval of such products, including electronic nicotine delivery systems intended for smoking cessation and related chronic
FDA Policy/General
The Justice Department has filed a civil complaint in a California federal court seeking a permanent injunction against Med-Pharmx and two individuals to prevent them from manufacturing and distributing animal drugs under conditions that fall short of the minimum regulatory requirements to ensure safety and quality. A Justice Department
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Necessary Automated External Defibrillator Accessories: Policy Regarding Compliance Date. The guidance revises FDA’s compliance policy on the deadline for filing PMA applications for previously cleared accessories necessary to operate automated external defibrillator systems. To view the notice, click
FDA Policy/General
Federal Register Notice: FDA has made available a final guidance entitled Referencing Approved Drug Products in Abbreviated New Drug Application Submissions. The document provides information to potential applicants on how to identify a reference listed drug, a reference standard, and the basis of submission in an ANDA submission. To view
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies. The document provides information intended to assist applicants design and conduct such studies that may be submitted as part of a modified risk tobacco product application,
FDA Policy/General
Federal Register notice: FDA has announced a 12/8-9 virtual public meeting entitled “The Drug Supply Chain Security Act Pilot Project Program and Enhanced Drug Distribution Security.” The meeting is intended to provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to discuss strategies
FDA Policy/General
Federal Register notice: FDA has announced a 12/16 Cardiovascular and Renal Drugs Advisory Committee meeting. Panel members are scheduled to discuss spironolactone for the proposed treatment of heart failure with preserved ejection fraction. Data supporting the new indication are from post-hoc analyses of the National Heart, Lung, and