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August 12, 2020

New Recommendations for Naloxone

[7/23/2020] To reduce the risk of death from opioid overdose, the U.S. Food and Drug Administration has made the following recommendations about the opioid reversal medicine, […]
August 12, 2020

Prescription to Over-the-Counter (OTC) Switch List

January 1 through July 13, 2020 NDA Drug Name Purpose Approval Date NDA 206276/S-005  Pataday Once Daily Relief (olopatadine hydrochloride, 0.7%) Temporary relief of itchy eyes […]
August 12, 2020

Oxford Medical Instruments USA, Inc. – 609104 – 08/11/2020

Product: Drugs Recipient: Recipient Name Istvan Magyar Recipient Title CEO Oxford Medical Instruments USA, Inc. 2173 Salk Avenue, Suite 250Carlsbad, CA 92008United States [email protected] WARNING LETTER […]
August 12, 2020

Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry

Submit Comments by 11/09/2020 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
August 12, 2020

Male Breast Cancer: Developing Drugs for Treatment

Submit Comments by 09/11/2020 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
August 11, 2020

Coronavirus (COVID-19) Update: Daily Roundup August 11, 2020

For Immediate Release: August 11, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
August 11, 2020

CDER Small Business and Industry Assistance (SBIA) Regulatory Education for Industry (REdI): Generic Drugs Forum April 4-5, 2017

[embedded content] Presentations You are invited to this two-day FDA led Regulatory Education for Industry (REdI): Generic Drugs Forum 2018. Join over 1000 participants from across […]
August 11, 2020

Expiration date extensions of certain lots of doxycycline hyclate capsules

FDA alerts government public health and emergency response stakeholders of additional expiration date extensions of certain lots of doxycycline hyclate 100 mg capsules manufactured by West-Ward […]
August 11, 2020

UPDATED PUBLIC PARTICIPATION INFORMATION: August 31, 2020: Meeting of the Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement – 08/31/2020 – 08/31/2020

On This Page Date: August 31, 2020 Time: 10:00 AM – 4:00 PM ET UPDATED INFORMATION (as of 8/11/2020): The public participation information has been changed. […]
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