Alan Minsk

Alan Minsk

Arnall Golden Gregory LLP

Contact

Readers' Choice Awards

Life Sciences
Life Sciences
Life Sciences
Life Sciences
Life Sciences
Life Sciences
Life Sciences
View Bio
RSS

Latest Posts › Food and Drug Administration (FDA)

Share:

AGG Food & Drug Newsletter - January 2020

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug Practice....more

1/24/2020  /  510(k) RTA , California Consumer Privacy Act (CCPA) , Data Collection , Data Privacy , Food and Drug Administration (FDA) , Medical Devices , Nutrition Facts Labels , Personal Information

FDA Final Order Exempts Certain Class I and II Medical Devices from 510(k) Premarket Review

On December 30, 2019, the Food and Drug Administration issued a final order that exempts certain class I and class II medical devices from 510(k) premarket review, subject to certain limitations....more

1/16/2020  /  510(k) RTA , Food and Drug Administration (FDA) , Medical Devices

AGG Food & Drug Newsletter - November 2019

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

11/27/2019  /  Centers for Medicare & Medicaid Services (CMS) , CGMP , Food and Drug Administration (FDA) , Manufacturers , OPDP , Open Payments , Over The Counter Drugs (OTC) , Pharmaceutical Industry , Warning Letters

A Very Fine Line — Split Decision: FDA Issues Draft Guidance on Clinical Decision Support Software

From his 1986 “Back in the High Life” album, Steve Winwood sings, “It’s a fine line, a very fine line – split decision.” In fact, that’s what many medical device companies will face as they review the Food and Drug...more

11/26/2019  /  Draft Guidance , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Medical Devices

Déjà Vu All Over Again: OPDP Sends Another Letter Regarding Website Promotion of an Investigational New Drug

On November 1, 2019, the Food and Drug Administration’s (FDA)Office of Prescription Drug Promotion (OPDP) sent an Untitled Letter to the sponsor of an investigational new drug that is being studied to treat brain cancer. ...more

11/26/2019  /  Food and Drug Administration (FDA) , OPDP , Pharmaceutical Industry , Prescription Drugs

AGG Food & Drug Newsletter - October 2019

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

10/31/2019  /  510(k) RTA , Food and Drug Administration (FDA) , Medical Devices , OPDP , Pharmaceutical Industry , Prescription Drugs

Medical Device Developments: FDA Finalizes Four 510(k) Guidance Documents

In September, the U.S. Food and Drug Administration issued multiple final guidance documents related to the medical device program. ...more

10/30/2019  /  510(k) RTA , Food and Drug Administration (FDA) , Medical Devices

FDA Considers How to Evaluate the Safety of the Materials Used in Medical Devices

On September 30, 2019, Jeff Shuren, Director of the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) issued a statement to announce the most recent updates to the agency’s attempts to evaluate...more

10/28/2019  /  Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry

OPDP Issues Two Enforcement Letters: Continuing Focus on Promotion of Drugs with Serious Risks & Drugs for Diseases With...

On September 13, 2019, FDA’s Office of Prescription Drug Promotion (OPDP) issued a Warning Letter stating that a professional email made false or misleading claims and representations about the risks and effectiveness...more

10/8/2019  /  Food and Drug Administration (FDA) , OPDP , Pharmaceutical Industry , Prescription Drugs , Warning Letters

AGG Food & Drug Newsletter - September 2019

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

9/30/2019  /  Anti-Competitive , Competition , FDA De Novo Clearance , Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , Made in the USA , Pharmaceutical Industry

FDA Releases Guidance on Acceptance Review for De Novo Classification Requests

On September 9, 2019, the Food and Drug Administration released a final guidance document, Acceptance Review for De Novo Classification Requests, to clarify the content that companies need to include in de novo requests to...more

9/25/2019  /  510(k) RTA , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry , Premarket Approval Applications

AGG Food & Drug Newsletter - August 2019

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

8/29/2019  /  Advertising , Antitrust Litigation , Class Action , Eliminating Kickbacks in Recovery Act of 2018 (EKRA) , Food and Drug Administration (FDA) , Medical Devices , OPDP , Pharmaceutical Industry , Prescription Drugs

FDA Says a Medical Device Sterilizer’s Promotion Is Too Hot to Touch

The Food and Drug Administration, channeling Kool & The Gang’s 1979 hit, “Too Hot,” issued a Warning Letter to a medical device company that marketed a sealed sterilization container for unlawful promotion. ...more

8/28/2019  /  Food and Drug Administration (FDA) , Medical Devices , Pharmaceutical Industry , Warning Letters

Attention Pharma Industry: Update your Drug Product Listings Now (FDA Will Begin to Deactivate Old and Outdated Listings Soon)

FDA recently reminded pharmaceutical manufacturers and other registered drug establishments to confirm that all product listing records are current and to remove outdated listings. The agency will soon begin deactivating old...more

8/28/2019  /  Food and Drug Administration (FDA) , Manufacturers , Pharmaceutical Industry , Prescription Drugs

AGG Food & Drug Newsletter - May 2019

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

5/28/2019  /  Centers for Medicare & Medicaid Services (CMS) , Department of Justice (DOJ) , Drug Pricing , Food and Drug Administration (FDA) , Jazz Pharmaceuticals , Kickbacks , Medical Devices , Patient Assistance Programs , Pharmaceutical Industry , Prescription Drugs

FDA Has Not Gone Away When It Comes to Unlawful Medical Device Promotion: Companies Receive Warning Letters for Violative...

In April 2019, the Food and Drug Administration issued two Warning Letters to medical device manufacturers, reminding industry that the agency will take enforcement action against unlawful promotion when it sees fit. One...more

5/15/2019  /  Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Warning Letters

AGG Food & Drug Newsletter - April 2019

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

4/15/2019  /  Artificial Intelligence , Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , Medical Devices , Pharmaceutical Industry

FDA’s Steps Toward a New Review Framework for Medical Devices That Use Artificial Intelligence Algorithms

On April 2, 2019, the Food and Drug Administration issued a statement by Commissioner Scott Gottlieb on steps toward a new review framework specifically tailored to promote the development of medical devices that use...more

4/12/2019  /  Algorithms , Artificial Intelligence , Food and Drug Administration (FDA) , Health Technology , Medical Devices , Popular

Rx Drug and Medical Device Advertising & Promotion – Considerations and Predictions for 2019

AGG recently presented a webinar on “FDA Regulation of Rx Drug and Medical Device Advertising & Promotion: The Year in Review.” The webinar focused primarily on enforcement letters and three guidance documents issued by the...more

2/11/2019  /  Advertising , Food and Drug Administration (FDA) , Medical Devices , OPDP , Pharmaceutical Industry , Prescription Drugs

Medical Device Landscape: Additional Developments for the 510(k) Pathway

In 2018, the Food and Drug Administration announced several actions relevant to the 510(k) premarket notification regulatory pathway. AGG has previously written about some of these, such as the pilot expansion of the Special...more

1/29/2019  /  510(k) RTA , FDA Approval , Food and Drug Administration (FDA) , Medical Devices , Pharmaceutical Industry

It’s De Novo All Over Again: FDA Issues a Proposed Rule to Implement the De Novo Classification Process

In December 2018, the Food and Drug Administration issued a proposed rule that would amend the medical device classification regulation to implement the De Novo classification process. ...more

1/23/2019  /  510(k) RTA , Draft Guidance , FDA De Novo Clearance , Food and Drug Administration (FDA) , Medical Devices

Pharma Supply Chain Cornucopia: More FDA Guidance on DSCSA Product Identifier and Verification Requirements

So far this Fall, the Food and Drug Administration (FDA) has issued four guidance documents regarding the product identifier and verification systems requirements of the Drug Supply Chain Security Act (DSCSA). ...more

11/8/2018  /  Comment Period , DSCSA , Food and Drug Administration (FDA) , Manufacturers , Pharmaceutical Industry , Prescription Drugs , Product Identifiers , Product Packaging , Supply Chain

FDA Releases an Internal Policy on Inspections (Selection of Drug Manufacturing Sites for Inspection)

The Food and Drug Administration (FDA) has released an internal policy related to risk-based scheduling and prioritization of surveillance inspections for drug manufacturing facilities. ...more

10/24/2018  /  Food and Drug Administration (FDA) , Inspections , Manufacturers , Pharmaceutical Industry

FDA Launches Pilot to Expand the Special 510(k) Program

On October 1, 2018, the Food and Drug Administration (FDA) announced a pilot expansion of the Special 510(k) Program. The Special 510(k) Program was developed to help streamline the 510(k) premarket notification process for...more

10/24/2018  /  510(k) RTA , Draft Guidance , Federal Pilot Programs , Food and Drug Administration (FDA) , Manufacturers , Medical Devices

AGG Food & Drug Newsletter - August 2018

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

8/28/2018  /  Department of Justice (DOJ) , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Opioid , Pharmaceutical Industry , Prescription Drugs , Warning Letters
240 Results
 / 
View per page
« Previous
Page: of 10
Next »

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide