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Pharmaceutical Industry The United States Food and Drug Administration

Continuing Coverage of FDA’s Crackdown on Stem Cell Clinics: Florida Clinic Cited for Unapproved Marketing and Inadequate...

by Hogan Lovells on

On the same day that FDA’s Commissioner, Dr. Scott Gottlieb, announced new policy initiatives regarding stem cell therapies and regenerative medicine, FDA announced stepped up enforcement in this area and posted a warning...more

FDA Announces Biosimilar User Fee Act Rates for FY2018

by Goodwin on

Last week, the FDA announced the Biosimilar User Fee Act (BsUFA) rates for the 2018 federal fiscal year, which runs from October 2017 through September 2018. The FDA determined these rates pursuant to the Food and Drug...more

AGG Food and Drug Newsletter - September 2017

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

United States ex rel Campie v. Gilead Sciences: Ninth Circuit Revives FCA Suit Despite Escobar’s “Demanding and Rigorous”...

The United States Court of Appeals for the Ninth Circuit unanimously reversed dismissal of a False Claims Act Complaint in United States ex rel. Campie v. Gilead Sciences. The most notable aspect of the case is that the panel...more

New FDA Final Guidance on Medical Device Panel Meetings Provides Certain Changes to Timelines and Procedures

by Hogan Lovells on

On September 1, 2017, the Food and Drug Administration (FDA or the Agency) released a final guidance document discussing the procedures for Medical Device Advisory Committee meetings (or, panel meetings). The document,...more

You Can’t Pass the Regulatory Compliance Buck with a Quality Agreement; FDA Reiterates the Point in a Recent Warning Letter

by Arnall Golden Gregory LLP on

Companies can’t sign quality agreements and then say “we’re done.” This message was brought home with a recent Warning Letter issued by the Food and Drug Administration to a pharmaceutical company for violating current good...more

The Devil is Really in the Details: FDA Issues Warning Letter to a Drug Company for Disseminating False and Misleading Information

by Arnall Golden Gregory LLP on

They’re back. The Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP), which has been relatively quiet on the enforcement front, issued a Warning Letter to a pharmaceutical company for distributing...more

Congress Takes Up FDA Over-The-Counter (OTC) Drug Regulation Reform

by Holland & Knight LLP on

On September 13, the U.S. House of Representatives Energy and Commerce Committee’s Subcommittee on Health held a hearing to examine draft legislation to create a new user fee program and completely revamp the review process...more

FDA Approves First Avastin Biosimilar

FDA announced Thursday that it has approved Mvasi (bevacizumab-awwb), Amgen and Allergan’s biosimilar of Genentech’s Avastin (bevacizumab), a monoclonal antibody used in the treatment of a number of different cancers. Mvasi...more

FDA Embraces Real-World Evidence in New Final Guidance

by Hogan Lovells on

On August 31, 2017, the U.S. Food and Drug Administration (FDA) finalized its guidance document entitled, "Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices." The final guidance reiterates...more

FDA Approves Amgen’s Biosimilar of Avastin®

by Goodwin on

Today, the FDA announced that it has approved Mvasi® (bevacizumab-awwb), Amgen’s biosimilar of Genentech’s Avastin®. According to the announcement, Mvasi® is the first biosimilar that the FDA has approved for the treatment of...more

FDA Clarifies Trading Partners Under the DSCSA

by Reed Smith on

The Federal Food and Drug Administration (“FDA”) recently published a draft guidance to assist industry and State and local governments in understanding how to categorize entities in the drug supply chain in accordance with...more

Northern District of New York (Quickly!) Holds that the MDA Expressly Preempts Essure Suit

by Reed Smith on

A couple of weeks ago, our co-blogger, Mr. McConnell, published a post on the benefits of brevity. That post sprang from an argument before the JPML, but we can riff on it today as we examine a short and lovely decision from...more

FDA Accepts Applications for Rituximab and Filgrastim Biosimilar Candidates

by Goodwin on

According to press releases this week, the FDA has recently accepted two new Abbreviated Biologics License Applications (aBLA) for review. First, Adello Biologics yesterday announced that the FDA has accepted its aBLA for...more

The Growing Number of Civil, Criminal, and Legislative Investigations of Insys Therapeutics, Inc. by Federal, State, and...

by Arnall Golden Gregory LLP on

On September 6, 2017, the U.S. Senate Homeland Security and Government Affairs Committee (HSGAC) released a Minority Staff Report: Fueling An Epidemic: Insys Therapeutics and the Systemic Manipulation of Prior Authorization....more

FDA Commissioner Touts Seamless Clinical Trails, Use of Modeling and Simulation As Ways to Lower Drug Costs

In remarks at the Regulatory Affairs Professionals Society’s (RAPS) 2017 Regulatory Convergence Conference yesterday, U.S. Food and Drug Administration (FDA or the Agency) Commissioner Scott Gottlieb, M.D., spent considerable...more

FDA Marketing Exclusivity Periods Limited To Same Active Moiety

by Foley & Lardner LLP on

In Otsuka Pharm. Co., Ltd. v. Price, No. 16-5229 (D.C. Cir. Aug. 29, 2017), the U.S. Court of Appeals for the District of Columbia Circuit affirmed the district court decision upholding FDA’s “same moiety” test for defining...more

FDA announces major regulatory overhaul initiative

by DLA Piper on

In a major announcement, the FDA has started a process aimed at making significant and widespread changes to its regulations that will affect tens of thousands of businesses worldwide. On September 7, 2017, FDA announced...more

Coming soon from FDA? Streamlined safety information in prescription drug television ads

by DLA Piper on

Most people are by now familiar with prescription drug TV ads that provide lengthy (and often confusing) laundry-list descriptions of numerous potential safety risks (seemingly regardless of the severity or likelihood of the...more

FDA Issues Guidance on Hurricane Readiness for Medical Devices

The U.S. Food & Drug Administration (FDA) has issued important guidance on how to prepare for hurricanes when dependent on medical devices. FDA stresses that during hurricanes and other emergency situations, medical devices...more

FDA Recalls St. Jude Medical Pacemakers for Cybersecurity Patches

The Food and Drug Administration (FDA) has issued a recall of 465,000 St. Jude Medical pacemakers in order to push a mandatory firmware patch of vulnerabilities in six types of radio controlled cardiac pacemakers....more

Healthcare Law Update: September 2017

by Holland & Knight LLP on

OIG Advisory Opinions - Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized - On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more

FDA Implements a New “Concept of Operations” for Drug Inspections

The Food and Drug Administration (FDA) has announced implementation of a new “concept of operations” that seeks to improve FDA’s oversight over pharmaceutical manufacturers. The concept of operations complements FDA’s program...more

FDA Commissioner Announces Stem Cell Enforcement Shift, Plans to Develop Comprehensive Regenerative Medicine Policies

In a major public move that has been long-awaited by proponents of evidence-based stem cell science, FDA Commissioner Scott Gottlieb issued a lengthy statement on August 28, 2017 “on the FDA’s new policy steps and enforcement...more

Is the Dam Breaking? Over-the-Counter Hearing Aids

by BakerHostetler on

The FDA Reauthorization Act (H.R. 2430), recently signed into law by President Donald Trump, included the Over-the-Counter (OTC) Hearing Aid Act, which requires the Food and Drug Administration (FDA) to develop regulations...more

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