FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Howard Phillips, LLC Millerton, OK (5/8): FDA inspected the firm 10/2016 and documented significant GMP violations involving finished pharmaceuticals. For example, FDA said the firm does not
FDA Policy/General
Federal Register notice: FDA has requested comments related to the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program. The agency says it is seeking insight regarding the development and overall design/approach of the pilot program including program goals, pilot standards, design concepts, and overall program approach. Voluntary consensus standards
FDA Policy/General
Federal Register notice: FDA has announced the availability of a guidance for industry on “Three-Month Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule.” The document is intended to assist persons who manufacture, package, sell, offer to sell, distribute, or import for sale and distribution
FDA Policy/General
Scott Gottlieb was sworn in as FDA commissioner 5/11 by HHS secretary Tom Price, following a Senate vote 5/9. Gottlieb previously served as deputy FDA commissioner during the George W. Bush administration. Previously, he worked on implementing the Medicare drug benefit as a senior advisor at CMS, where
FDA Policy/General
The Trump Administration’s proposed budget for FDA in 2018, which cuts the agency’s budget authority (BA) by 37%, “is a non-starter,” writes Alliance for a Stronger FDA deputy director Steven Grossman in the 180-member organization’s 5/12 Friday Update. That’s because, he continues, “it
FDA Policy/General
The Senate Health, Education, Labor & Pensions Committee 5/11 voted 21-2 to advance S. 934, the FDA Reauthorization Act of 2017, that would reauthorize FDA’s user fee programs for another five years beginning 10/1. The measure includes new sections on pediatric drugs/devices, improvements related to
FDA Policy/General
Federal Register final rule: FDA is amending the animal drug regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during January and February. The agency is making available the summaries of the basis of approval and environmental review documents, where applicable. The
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of a new animal drug application at the sponsors’ request because the product is no longer manufactured or marketed: Sioux Biochemical’s NADA 009–505 for F.S.H.-P (follicle stimulating hormone) powder for injection. To view the notice, click here.
FDA Policy/General
The Senate Health, Education, Labor, and Pensions Committee postponed a 5/10 planned mark-up of a bill to reauthorize FDA’s user fee programs for another five years. It was postponed in response to president Trump’s firing of FBI director James Comey and a subsequent meeting of the
FDA Policy/General
Federal Register notice: FDA has announced the availability of draft revisions to the “FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics.” The Blueprint is part of the FDA-approved risk evaluation and mitigation strategy for extended release and long-acting opioid analgesic medications. FDA is
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Huron Pharmaceuticals, Farmington Hills, MI (4/20): FDA inspected the firm 12/2016 and cited significant GMP deviations for active pharmaceutical ingredients (API). For example, the firm repeatedly omitted
FDA Policy/General
The Senate Health, Education, Labor, and Pensions Committee has released a “Manager’s Amendment” to S. 934 FDA Reauthorization Act of 2017 that would reauthorize FDA’s user fee programs for another five years. The amendment was released in advance of a 5/10 mark-up by the committee, and
FDA Policy/General
FDA chief information officer Todd Simpson says the agency is implementing a cloud-based data management system to eliminate the need for duplicate storage at continuity of operations sites and minimize data center storage loads. Writing in an online post for CIO Review, Simpson says FDA conducted exhaustive market research
FDA Policy/General
The Project on Government Oversight (POGO) says an HHS 5/3 staff memo “gags employees from speaking with Congress and violates the Whistleblower Protection Enhancement Act of 2012.” The memo was released by Sen. Charles Grassley (R-IA) and Rep. Jason Chaffetz (R-UT). It says that any communication with
FDA Policy/General
Pediatric Panels to Review Duchenne Trial Protocol 05/02/2017 Federal Register notice: FDA announces a 5/18 joint Pediatric Advisory Committee and Pediatric Ethics Subcommittee meeting to discuss a referral by an Institutional Review Board of a clinical investigation that involves children with Duchenne muscular dystrophy. FDA Seeks Comments
FDA Policy/General
FDA is seeking comments from its Science Board on a draft work plan on 21st Century Cures Act Innovation Account Activities that prioritizes patient-focused drug development and qualification of drug development tools when monies are appropriated by Congress. The draft discusses how FDA is required under Cures to establish
FDA Policy/General
FDA reportedly has been ordered to replace CNN with Fox News broadcasts on internal video monitors across its White Oak, MD campus, but the agency is denying the allegation and indicated that various news channels are broadcasting in common areas around campus. Apparently, a screenshot of an internal FDA email
FDA Policy/General
Senate Health, Education & Pensions Committee leaders have scheduled a 5/10 mark-up of S 934 “Food and Drug Administration Reauthorization Act,” a bill to reauthorize the user fee agreements for the next five years. The measure reflects the recommendations sent by FDA to Congress in January, which were
FDA Policy/General
Federal Register notice: FDA has reopened the comment period regarding issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, and identifying system attributes that are necessary to implement the requirements established under the Drug Supply Chain Security Act (DSCSA). The information
FDA Policy/General
Federal Register notice: FDA has recently determined that a list of drug products were not withdrawn from sale for reasons of safety or effectiveness. This determination means that the agency will not begin the process to withdraw approval of ANDAs that reference the products, and it will allow the approval
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection for “Institutional Review Boards (IRBs) — 21 CFR 56.115 — OMB Control Number 0910–0130.” IRBs are required to create and maintain records describing their operations, and make the records available for FDA inspection when requested. Such records include: written
FDA Policy/General
FDA would see a $39 million boost in its fiscal year (FY) 2017 spending under a budget bill lawmakers unveiled Monday. Under the bill, the agency would receive $2.759 billion in discretionary funding, a little over 1% increase over the FY 2016 enacted level. Total FDA funding, including user