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FDA Finalizes Guidance on Process to Request Review of CFG Denial
…provisions of the Federal Food, Drug, and Cosmetic Act (FDCA) to establish specific procedural rights and appeal options for device companies faced with a CFG denial. The following year, FDA…
GAO Examines FDA’s Implementation of GDUFA: Application Review Times Have Improved, But the Agency Needs a Plan for Carryover Fees
…old. As of December 31, 2016, FDA had also acted on 89 percent of all ANDAs submitted in fiscal year 2015 within 15 months of receipt, exceeding its GDUFA goal…
Guidance on Guidance: Enforcement to be Curtailed
…rules. DOJ issued a memorandum directed at all DOJ civil litigators who bring affirmative civil enforcement (ACE) cases, defined as “civil lawsuits on behalf of the United States to recover…
New Legislation Would Cut Off Access To The Courts And Immunize FDA Actions From Timely Judicial Review
…the new bill rewrites FDC Act § 505(q)(2) in a manner that appears calculated to immunize FDA’s actual final approval decisions from timely judicial review. Specifically, the bill would amend…
Device Manufacturer’s Criminal and Civil Penalties Deserve Closer Attention
…manufacturer of medical devices derived from porcine urinary bladder material. ACell received a Warning Letter in 2013 related to the Quality System and Medical Device Reporting for its MatriStem® Surgical…
Seventh Circuit Decision in Caputo Finding a Device Company CEO & CCO Criminally Liable for Off-Label Marketing Could Significantly Affect Civil and Criminal Defense Strategies
…in civil cases, as well as criminal cases. The Seventh Circuit’s opinion also has an interesting discussion about the extent to which a manufacturer may modify a device that FDA…
Discovery in the BPCIA Era: Federal Circuit Rules in Amgen v. Hospira EPOGEN Biosimilar Dispute
…a decision from the Federal Circuit in an interlocutory appeal pending since July 2016 in the revised Amgen v. Hospira matter, Case 1:15-cv-00839 (D. Del.), No. 2016-2179 (Fed. Cir. 2017)….
The Government Really Means It This Time
…civil cases cannot use an individual’s inability to pay as a factor in deciding whether to bring a case against an individual. Ms. Yates recognizes that these cases “may not…
California Enacts Law to Increase Drug Pricing Transparency
On October 9, 2017, California Governor Jerry Brown signed into law a bill (SB 17), which imposes new notification and reporting requirements on pharmaceutical companies, health care service plans, and…
Getting Into the Weeds of USDA’s Hemp Production Program Regulations
…also submit monthly reports notifying USDA of any occurrence of non-conforming plants or plant material and the disposal or remediation record by the producer. Disposal and remediation reports must include:…
A Very Full Plate: FDA’s 5-Year Plan for Foods
…leadership, capacity, and partnership to support public health and animal health decision making,” with a focus on “mission-critical science capabilities.” “Provide accurate and useful information so consumers can choose a…
CFSAN Announces Science and Research Strategic Plan: Issues Range from Nanoparticles to Obesity
By Etan J. Yeshua – FDA has announced several key areas on which it plans to focus its food- and cosmetic-related research and regulatory efforts. The plan specifically names imported…
Judge Says Lack of State and Federal Plans Means That the Farm Bill’s Interstate Commerce Protections for Hemp Don’t Apply
…USDA can “approve” or disapprove” a state or tribal “plan,” or establish his own “plan.” Idaho argued that until such a plan is approved or established, no hemp can be…
CMS Proposes Rule to Reduce Drug Costs Under Medicare Part D and Medicare Advantage
…Part D policy requires that Part D plan sponsors include on their formularies, with limited exceptions, all drugs in six categories or classes: antidepressants, antipsychotics, anticonvulsants, immunosuppressants for treatment of…
International Plan of Mystery: ICH Guidelines for Generic Drugs
Back in October, FDA announced that it submitted a proposal to the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) for the development of common…