Kaleido Scope4y
Investigational Drugs or Biologics - Investigational New Drug (IND)
Principal Investigators on treatment protocols that involve an Investigational New Drug (IND) must complete Form FDA 1572, which the sponsor then submits to FDA. Form FDA 1572 is the contract between ...
JD Supra17d
Recent FDA Guidance Signals Future Growth for Decentralized Clinical Trials
On Sept. 18, 2024, the U.S. Food & Drug Administration (FDA) issued a final guidance document titled “Conducting Clinical Trials With ...
Indy 100 on MSN4h
FDA issue order against common ingredient found in cold and flu medicine
The US Food and Drug Administration (FDA) has proposed an order to ban a popular ingredient in cold and flu medicines as it is seemingly not as effective as other methods. Oral phenylephrine is often ...
FDA proposes ending use of decongestant found in many cold, allergy medicines
An extensive review determined that the ingredient, oral phenylephrine, doesn’t actually relieve nasal congestion.
FDA proposes removing ineffective decongestant found in most cold medicine
FDA officials said an agency review of the available data found oral phenylephrine is not effective as a nasal decongestant ...
Kellogg School of Management1y
IRB Studies
This sponsor will solicit related financial interest disclosures from study PIs and Sub-Is via the FDA Form 1572. The information required to be collected by the sponsor and disclosed by the PI and ...
Health on MSN3d
FDA Plans to Ban Ineffective Cold Medicine Ingredient—How It Will Affect You
The FDA has proposed removing phenylephrine, a widely used ingredient to treat nasal congestion, from over-the-counter cold medications.Last year, an FDA advisory committee concluded that the oral ...
Kaleido Scope3y
WCG IRB Connexus
Release of Drugs for Human Research Use (if any drugs will be used in the protocol) Radiation Safety Approval Infection Control Approval Release of Pathologic Materials FDA Form 1572 2. A member of ...
U.S. FDA proposes ending use of popular decongestant present in cold medicines
The U.S. Food and Drug Administration has proposed to remove oral phenylephrine, widely used in cold and cough syrups, as an ...
Monthly Prescribing Reference3h
FDA Extends Review of CNTF Ocular Implant for Macular Telangiectasia
NT-501 is an investigational ocular implant that utilizes an encapsulated cell-based delivery system to deliver continuous ciliary neurotrophic factor.
Newsweek on MSN3d
Texas Butter Recall Update as FDA Sets Risk Level
On Thursday, November 7, the FDA categorized this recall as a Class II, meaning: "a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse ...
Benzinga.com2y
FDA Calendar
A CRL is issued by the FDA when it deems that the regulatory application is not complete in its current form. The deficiencies usually that lead to rejection could be the need for additional ...