FDA Policy/General
The Trump Administration has temporarily blocked new FDA and other agencies’ Federal Register notices until they have been reviewed and cleared by a presidential appointee or designee. A memo entitled “Regulatory Freeze Pending Review” calls on agencies to not send regulation notices to the Office of the Federal Register (OFR)
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Porton Biopharma, Salisbury, United Kingdom (1/19): FDA inspected the firm’s facility 3/2016 and cited significant GMP violations. The agency cited similar GMP violations in a 2015
FDA Policy/General
Despite reports that the Trump Administration has issued an communication blackout at federal agencies, including FDA, an HHS official told FDA Webview 1/24 that no such order exists. PEN America, an organization that says it stands at the intersection of literature and human rights to protect open expression in
FDA Policy/General
The Trump Administration has reportedly added Fairleigh Dickinson University professor and executive director of the Lewis Center for Healthcare Innovation and Technology Joseph V. Gulfo to its short list of FDA commissioner candidates. Gulfo has gone on record to urge that FDA and Congress should develop a true conditional approval
FDA Policy/General
On his first official working day in office, president Donald Trump has pledged to “cut regulations by 75%, maybe more.” Without releasing any details, particularly how it may apply to FDA and its regulated drug, biologic and medical device industries, Trump did say there will still be government regulation, “and
FDA Policy/General
President Donald Trump 1/23 signed a presidential directive to freeze government-wide hiring, except for the military. The White House did not immediately release the directive’s text, and FDA declined to comment on the hiring freeze’s impact on the agency, instead directing any questions to the White
FDA Policy/General
Former FDA Office of Criminal Investigations director George Karavetsos has joined DLA Piper in the firm’s litigation practice as a partner in its Miami office. Karavetsos resigned from FDA, effective 1/20, amid Capitol Hill criticism and an investigation into OCI’s management and possible morale issues with field
FDA Policy/General
Federal Register Notice: FDA has confirmed a 12/2/2016 effective date for a final rule that appeared in the 11/1/2016 Federal Register that amended the color additive regulations to provide for the safe use of titanium dioxide and [phthalocyaninato (2-)] copper to color orientation marks for intraocular
FDA Policy/General
Federal Register Notice: FDA has determined that Acthar Gel Synthetic (seractide acetate) injection, 80 units/milliliter (mL) and 40 units/mL, was withdrawn from sale for reasons of safety or effectiveness. The agency will not accept or approve ANDAs that reference the product because of this determination. To view the
FDA Policy/General
Federal Register Notice: FDA is seeking comments on an information collection extension related to “Premarket Approval of Medical Devices.” To view the notice, click here.
FDA Policy/General
A Senate Finance Committee Hearing 1/24 will consider the nomination of president Trump’s pick to lead HHS, House Budget Committee chair Tom Price (R-GA) (see earlier story). Committee members are expected to grill Price on ethics concerns. Earlier this month, he agreed to divest stock ownership in
FDA Policy/General
Eli Lilly has signed an agreement to acquire CoLucid Pharmaceuticals $960 million. The acquisition would boost the company’s existing portfolio in pain management for migraine and also add a potential near-term launch to its late-stage pipeline. “Lasmiditan is a novel, first-in-class molecule that could represent
FDA Policy/General
In his last role as FDA commissioner, Robert Califf has penned a JAMA online article calling for a harmonized risk-benefit assessment across the medical product Centers. “Realization of a harmonized benefit-risk framework across the agency will require firm commitment to evaluating cultural and scientific reasons for variation in
FDA Policy/General
Federal Register Notice: FDA has made available a draft guidance for “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities — Questions and Answers.” The guidance provides answers to common questions on communicating health care economic information about approved prescription drugs by medical product manufacturers, packers, distributors, and
FDA Policy/General
Federal Register Notice: FDA has made available a draft guidance on “Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers.” The document provides information for manufacturers, packers, and distributors of drugs and medical devices for humans, including those that are licensed as biological products, and
FDA Policy/General
Federal Register Notice: FDA has canceled a 2/16-planned Psychopharmacologic Drugs Advisory Committee meeting that was announced in the 12/27/2016 Federal Register. Panel members were scheduled to review a Neurocrine Biosciences NDA for valbenazine 40 milligram (mg) capsules, indicated for treating Tardive Dyskinesia. To view the notice,
FDA Policy/General
Federal Register Notice: FDA has reopened the comment period concerning its comprehensive review of regulations and policies governing manufacturer communications about unapproved uses of approved or cleared medical products. The agency has also made available “Memorandum: Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses
FDA Policy/General
FDA says it is abandoning a controversial embargo policy directed at reporters that came to light last year by New York University journalism professor Charles Seife. In a lengthy analysis for Scientific American, Seife said that by holding embargoed briefings for select reporters on major issues conditional that the reporters
FDA Policy/General
Federal Register Notice: FDA is seeking comments on an information collection extension for its “Adverse Event Program for Medical Devices (Medical Product Safety Network — MEDSUN).” FDA is seeking OMB clearance to continue to use electronic data collection to obtain the information on Form FDA 3500A related to medical devices and
FDA Policy/General
[Analysis by Jim Dickinson] While the Obama administration’s defense of FDA was, fundamentally, as feeble as its latter-day predecessors, the FDA-relevant signs from the incoming Trump Administration are that the very idea of FDA defense could be out the window. The agency’s bedrock premise – proof of
FDA Policy/General
Federal Register Notice: FDA has made available a draft guidance for industry entitled “Considerations in Demonstrating Interchangeability With a Reference Product.” The document is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing application
FDA Policy/General
Federal Register Notice: FDA has made available a guidance entitled “Assessment of Abuse Potential of Drugs.” The document is intended to assist sponsors of investigational new drugs and applicants for approval of a new drug in evaluating whether their new drug product has abuse potential. Specifically, it provides recommendations for