FDA Policy/General
In a Securities and Exchange Commission (SEC) case that could affect FDA and several other government agencies that routinely seek disgorgement, the Supreme Court has agreed to consider the question of whether the SEC has the legal authority to seek disgorgement. The case follows a unanimous high court 6/2017
FDA Policy/General
Federal Register notice: FDA is announcing a 12/6 public workshop on incorporating clinical outcome assessments into endpoints for regulatory decision making. The workshop’s discussions will be used in developing patient-focused drug development guidance as required by the 21st Century Cures Act and as part of commitments agreed
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications — 21 CFR Part 3” (OMB Control Number 0910-0523). Agency regulations permit it to determine the organizational component within FDA assigned to have primary jurisdiction for
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. MSM Nutraceuticals, Phoenix, AZ (10/24): FDA inspected the firm in May and cited significant GMP violations for finished pharmaceuticals. For example, MSM failed to perform, for each batch
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Format and Content Requirements for Over-the-Counter Drug Product Labeling — 21 CFR Part 201” (OMB Control Number 0910-0340). The collection supports FDA regulations that establish standardized content and format requirements for OTC drug product labeling,
FDA Policy/General
AMPAC Fine Chemicals has acquired UniTao Pharmaceuticals’ active pharmaceutical ingredient manufacturing facility in Petersburg, VA. The facility includes four plants with multiple cGMP manufacturing lines totaling more than 80,000 gallons of cGMP capacity. It has a long history of producing Schedule II controlled substances, and its capabilities include high
FDA Policy/General
President Donald Trump told reporters at the White House 11/8 that the administration’s new rules on e-cigarettes should be out within a week. An element in the plan will involve raising from 18 to 21 the legal age for purchasing vaping products, he said. The Hill reports
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of a Haemonetics ANDA for Anticoagulant Citrate Dextrose SolutionA, USP, in plastic bags because the company notified the agency that the drug is no longer being marketed. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled for “Controlled Correspondence Related to Generic Drug Development OMB Control No. 0910-0797." The revision responds to goals negotiated under the generic drug user fee program, which commits the agency to responding to questions submitted as
FDA Policy/General
Federal Register notice: FDA is seeking comments on a draft document that details best practices for drug safety surveillance entitled “Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff.” The document discusses risk-based principles that support ongoing FDA postmarketing safety surveillance for drug and biological
FDA Policy/General
The Alliance for a Stronger FDA is advocating for increased FDA funding in fiscal year 2020 because “growing responsibilities require a budget that grows.” That was the message during an 11/6 Webinar from Alliance deputy executive director Steven Grossman as he discussed FDA’s positioning in the current funding
FDA Policy/General
Federal Register notice: FDA has published a list of eight information collections that have been approved by OMB. They are: * Agreement for Shipment of Devices for Sterilization * Substances Prohibited fromUse in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed * Clinical Laboratory Improvement Amendments Waiver Applications * Registration and Product
FDA Policy/General
The Senate Health, Education, Labor & Pensions Committee has scheduled an 11/20 confirmation hearing for FDA commissioner nominee Stephen Hahn. President Trump nominated the MD Anderson chief medical officer 11/1, the same day former acting commissioner Ned Sharpless was ordered back to his previous position as National Cancer
FDA Policy/General
Federal Register notice: FDA is seeking industry organizations to participate in selecting a nonvoting industry representative to serve on CBER’s Allergenic Products Advisory Committee. A nominee may either be self-nominated or nominated by an organization. Industry organizations interested in participating must send a letter stating that interest to
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says it wants to do research to assess terms and phrases commonly used in prescription drug promotion. A Federal Register notice says the research will look at how consumers and primary care doctors interpret these expressions. It will look at both how
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: Bingbing Pharmaceutical, Shiyan Shi Hubei Sheng, China (10/3): FDA inspected the firm in May and cited significant GMP violations for finished
FDA Policy/General
Politico’s Prescription Pulse online newsletter says that FDA principal deputy commissioner Amy Abernathy has been named the agency’s acting chief information officer and begun an overhaul of its tech structure. She tells Prescription Pulse she became acting chief information officer “because it became clear that the first thing
FDA Policy/General
Hep D Virus Drug Development Guide Federal Register notice: FDA makes available a draft guidance entitled “Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment.” 11/01/2019 Draft Guide on Generic Drug User Fees Federal Register notice: FDA makes available a draft guidance entitled “Assessing User Fees under the
FDA Policy/General
Ligand Pharmaceuticals has entered into a worldwide license agreement with xCella Biosciences to permit xCella to use the OmniRat, OmniMouse and OmniFlic platforms to discover fully human mono- and bispecific antibodies. Ligand is eligible to receive annual platform access payments, development and regulatory milestone payments and royalties for each product
FDA Policy/General
DEVICES FDA has approved an Acclarent de novo petition to permit marketing of the Aera Eustachian Tube Balloon Dilation System for treating persistent eustachian tube dysfunction (ETD), a condition in which pressure, pain or clogged or muffled sensations occur in the ear. FDA has approved a Medtronic PMA for the
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment.” The document addresses the agency’s current recommendations for the overall development program and clinical trial designs for developing such drugs/biologics. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Assessing User Fees under the Generic Drug User Fee Amendments of 2017.” The document provides stakeholders information about user fee policies and procedures. It revises and replaces FDA’s earlier draft guidance under the same titled published 10/2017.